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Schizophrenia Update

A Free Periodic Newsletter Brought to you by www.schizophrenia.com

Series 2, Issue 7 - Oct. 14, 2003

 

A Summary of Schizophrenia-related News and Events

Note: Please forward this newsletter to others who might benefit

To Subscribe to the newsletter, enter your email address at: www.schizophrenia.com

To Unsubscribe or change your email address, go to the bottom of the newsletter

and click on the appropriate link.

 

Recent Back-issues of this newsletter are now available at

http://www.schizophrenia.com/newsletter/allnews/allnews.htm

Join the 19,000+ people who use the Schizophrenia Support Groups at: www.schizophrenia.com

Schizophrenia.com is a registered non-profit organization

Letters to the Editor can be sent to the following email address: news@schizophrenia.com

Special Thanks to Viswanath, a volunteer helping providing news story identification

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TABLE OF CONTENTS

bullet
bullet
bullet How do you participate in a transcranial magnetic stimulation (TMS) trial?
bullet International Email Support Groups - Looking for people in India
bullet Inexpensive Schizophrenia Medications in India
bullet
bullet Stimulating Childhood Environment May Curb Schizophrenia
bullet E-psychiatrist for quick diagnosis of Schizophrenia
bullet Late-onset schizophrenia can lead to dementia
bullet FDA Seeks Diabetes Warning on Anti-Psychotic Drugs
bullet New Movie Review: Man's descent into schizophrenia avoids cinematic stereotype
bullet FDA Approves ABILIFY(TM) (Aripiprazole) for Maintaining Stability in Patients With Schizophrenia
bullet Solvay Pharmaceuticals and Lundbeck move into Phase III Clinical trials with joint schizophrenia treatment, Biferprunox

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Recommended Books on Schizophrenia

We've recently added a new section to our web site that identifies good books covering schizophrenia. Whether you're just learning about schizophrenia, or already know a great deal - please review our list at the link below and we think you'll find something of interest.

If you're going to buy any of these books, please do so through the links provided, as Amazon provides us a commission that helps fund our web site development. If you would like to recommend a book that we haven't identified, please let us know by sending us an email, with a description on why you liked it.

Recommended Books: http://www.schizophrenia.com/media/books.html

Following is a list of the different areas we cover in the list:

bullet Introductory Books on Schizophrenia
bullet Day-to-Day Coping Strategies for Families
bullet Schizophrenia Medications (Anti-psychotics)
bullet Financial Planning with a Mentally ill Child
bullet Housing and Accomodation for the Mentally Ill
bullet Personal, Hopeful Stories on Schizophrenia
bullet Books for brothers and sisters, and Sons and Daughters of people with Schizophrenia
bullet Chidren's Books on Mental Illness/Schizophrenia
bullet More Advanced Books on Schizophrenia and the Biology and Genetics behind it
bullet Professional Books on Schizophrenia and Psychiatric Drugs
bullet Schizophrenia - Stories of Tragedy
bullet Schizophrenia in Society - Homelessness, Poverty, and other issues
bullet Audiocassette Stories on Schizophrenia
bullet Films and Videos on Schizophrenia
bullet Recent Major Movies Covering People with Schizophrenia
bullet Fictional Books Involving People with Schizophrenia
bullet Good books for High School Students doing reports on Schizophrenia

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Letters to the Editor:

How do you participate in a transcranial magnetic stimulation (TMS) trial?

With regard to the story in the last newsletter, How does one arrange for the possibility of a clinical trial on the transcranial magnetic stimulation(TMS) which was reported on as being very helpful in reducing the problem of auditory hallucinations by people with schizophrenia?

Editor's Response:

I recommend you contact Yale University and get details. Here is a web page that has more info, and see below for details - good luck!

http://info.med.yale.edu/psych/clinics/rTMS.html

More Facts About the TMS/Hallucination Clinical Trials Participation in these clinical trials requires approximately 2-4 weeks. Prior to entering the study the patient receives medical, psychiatric and neurological evaluations. Patient volunteers are reimbursed $300 for completing the treatment study and $50 per brain scan. Brain scans do not require any injections. If patients live a considerable distance from New Haven or have severe symptoms, they can be hospitalized at no cost on a research unit at the Connecticut Mental Health Center in order to participate in the study. Otherwise, participation can be on an outpatient basis. We are also interested in contacting people who experience voices and would be willing to consider enrolling in brain imaging studies, though not necessarily a TMS clinical trial. The purpose of these studies is to better understand brain mechanisms that produce voices and other related symptoms. Payment for participating in these brain-imaging studies is $75. Studies described above are approved by the Yale University School of Medicine Human Investigation Committee (HIC #9281, 12679 and 7363). For more information or to make a referral, call Maxine Varanko, Study Coordinator, at 203-737-2762 (maxine.varanko@yale.edu)

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International Email Support Groups for Schizophrenia

India - Email Support Group for Families Impacted by Schizophrenia

Dear Schizophrenia.com, Do you have others on your list who are from India I would like to establish contact with them if there are any. India is still mired very deeply in treating schizophrenia as something not be discussed or spoken about, as my son of 19 has been been diagnosed as one. I am keen to be part of a like minded support group here which could at least interact on mail and give encouragement to each other.

Regards Monica in India. Email: monica_141@hotmail.com

EDITOR: Monica - yes, we have many subscribers (probably over 100 people) from India. I encourage them to send you an email if you are interested, at your above address. I think this is a great idea - schizophrenia is such a difficult disease with so few resources we all need to work together.

In fact I think this is such a good idea, I'd like to expand this idea to create email support groups for anyone in any country. Right now we have the general support discussion groups on the Schizophrenia.com web site - but I know that the issues that people face in countries varies a great deal, so I'm sure that others would be interested in setting up small, regional support groups. If there are other people out there in different countries who would like to meet other parents of individuals with schizophrenia to share information and resources - please send us an email. If people will volunteer to be "Country Support Group" hosts - we could create a page on the web site with email addresses of these hosts for small email support groups in each country. I think it would help a lot of people. For more information please see:

http://www.schizophrenia.com/International/internationalsupport.html

Brian

To Start an International Email Support Group - please send an email to news@schizophrenia.com and let us know your interest, and your country.

Inexpensive Schizophrenia Medications in India

Dear Schizophrenia.com

I live in America, where my son needs 30 mg Olanzapine (Zyprexa) every day. From Eli Lilly, each tablet costs around $10 US. However, I travel to India regularly, where I can buy Olanzapine, under the trade name "Olanex", manufactured by the Solus group of Ranbaxy, for 10 cents (USD 0.10) for each 10 mg tablet. My son has been on Olanex for over a year, and my observations, and those of his doctor, confirm that Olanex works as well, and is the same molecule, as Olanzapine. Even an Eli Lilly rep, that I bumped into at an airport, admitted that Olanex was as good. The only difference is that I am $10,000 US per year better off.

You might wish to pass this onto your readers, some of whom might want to take a week's holiday, see the Taj Mahal, and still save a load of cash.

Regards,

J.

-----------------

Dear J,

Thanks for your email - it sounds like you've found a little loophole that is similar to, but even better than, the cheap medications from Canada that have been in the news a lot recently in the USA. I've done a little research on the Internet (using Google.com) on "Olanex"- and in fact it seems that your information is accurate in that Olanex is an inexpensive generic version of Olanzapine that is only available in India - but people should do their own research to validate this information further. For people who don't have insurance and can't afford the yearly cost of Olanzapine, this might be a way to still obtain this important medication. Following are some news items that may be of interest to people on this topic, from Indian web sites.

Hope for the sick in mind, by Dr Rajeev Gupta http://www.tribuneindia.com/2000/20000524/health.htm#3

In fact, it appears that there may be a number of generic anti-psychotic medications: (Note: The exchange rate is approximately $1 for 45 Indian Rupees) and the medications seem to come in packages of 10 tablets (someone from India please correct me here if I am incorrect).

Information From Medclik - an Indian Pharmaceutical Organization's web site: http://www.medclik.com

http://www.medclik.com/drugmanual/showbrands.asp?genericid=561

Antipsychotics & Antimanics Information

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Study shows childhood development factors may correlate to schizophrenia (University of Southern California DailyTrojan)

By JACQUELINE LEE
Contributing Writer

Children with better nutrition, regulated exercise and a more nurturing educational experience are less likely to develop schizotypal personality disorder, a disorder that marks the stage before schizophrenia, according to a 20-year study led by a USC professor.

The study, conducted by Adrian Raine, a professor of psychology and neuroscience, was the first ever to research how to prevent the disorder rather than just treat it. The results were published in the September issue of The American Journal of Psychiatry.

"I've had some cases of mental illness in my family," said Sarnoff A. Mednick, director of the social science research institute and a professor in psychology. "Schizophrenia is a major problem in the world. We started this study 20 years ago to determine earlier characteristics of this disorder so that we could prevent it from happening to people."

Mednick and Peter Venables, another professor, started the research study in 1972. Raine took over the project in 1987 because he was interested in narrowing down the research and testing specific components as causes of the disorder.

In the study, a group of 438 children from the island of Mauritius in the Indian Ocean, ranging in ages three to five, were volunteered to participate in the study.

"Mauritius is the ideal location because of its geographical and social advantage," Raine said. "Very few people come and leave from Mauritius, which is good for our research purposes. Imagine keeping track of 400 3-year-olds in Los Angeles, and try to see where they are a decade or two later. It would be impossible."

The children were randomly divided into two groups: 83 children were assigned to be in the environmental-enriched group, while 355 children were designated the control group.

For two years, the environmental-enriched group received better nutrition, regulated exercise and a more nurturing educational experience. The group was given regular hot meals consisting of fish, mutton or chicken, a green salad, and milk. The control group ate the typical island meal of bread and rice.

The environmental-enriched group exercised for two and a half hours, while the control group did not have exercise as a part of their school life besides regular free play.

The type of education received by the two groups also differed greatly. The tested group had an emphasis on verbal skills, building a stronger memory, concepts of love and basic behavior of society.

After two years, both groups were released to function in normal societal life. The groups were evaluated when they reached ages 17 and 23 to compare the criminal and social records.

At age 17, the enriched group had a 32 percent reduction of schizotypal personality traits and a 28 percent reduction in anti-social behavior problems compared to the control group. At age 23, the enriched group had a 35 percent reduction of schizotypal behavior and a 64 percent reduction in anti-social behavior.

"The experiment needs to be replicated in other areas around the world in order for us to absolutely determine whether schizophrenia stems from environmental factors," Raine said. "We haven't solved it, but now we have insight. The research suggests that schizophrenia has its origins early in life and is due to proper nutrition, exercise and a nurturing education environment."

The World Health Organization (WHO), the United States National Institute of Health and the Mauritius government funded the study.

WHO was interested in researching child development in a developing country, Raine said.

"Only 1 percent of the population has schizophrenia. What is more common, however, is schizotypal personality disorder, which the study is based on," Raine said. "Schizotypal personality disorder is the preliminary stage of schizophrenia, and about 5 percent of the population has traits of a schizotypal personality. "

There are nine traits of a schizotypal personality; a person who possesses five out of these nine traits is diagnosed as schizophrenic, Raine said.

People who are schizophrenic may see an accident and strongly believe that they somehow caused it. They may have odd beliefs in things such as UFOs, tarot cards or their sixth sense.

Schizophrenics tend to lack close friends, have an eccentric appearance and have blunted emotional _expression.

Other characteristics of schizophrenics include people who believe they have perceptual experiences, odd thinking and speech patterns, strong paranoia and excessive anxiousness.

"My friend's mom was schizophrenic. She used to check her backyard constantly for people parachuting onto her property," said Daniel Kilpatrick, a junior majoring in psychology.

"When my friend's family went to Hawaii, she wouldn't leave the hotel room for two weeks because she was reading death threats and license plates."

Although cases of schizophrenia in the population are rare, the disorder affects society in other ways.

"USC students should be aware of schizophrenia because statistics show that most people become schizophrenic between the ages of 18 to 21," Raine said.

"As young adults on the verge of developing families of their own, it would be vital for them to know how schizophrenia may be prevented if they decide to have children."

 

Source: http://www.dailytrojan.com/article.do?issue=/V150/N14&id=03-prof.14c.html

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Stimulating Environment May Curb Schizophrenia
Fri Oct 10

NEW YORK (Reuters Health) - An enriched, stimulating environment during childhood seems to reduce the likelihood of developing schizophrenia and criminal behavior in young adulthood, according to a study in Mauritius.

Although several reports have suggested a link between environmental factors and these mental health problems, few studies have looked at early childhood interventions as a means of preventing them.

Dr. Adrian Raine, from the University of Southern California at Los Angeles, and colleagues assessed the effects of an environmental enrichment program at ages 3 to 5 years on the risk of schizophrenic-like personality and antisocial behavior at ages 17 and 23 years.

The study involved 438 children from Mauritius who were born in 1969 or 1970. Half participated in the special program while the remainder experienced the usual community conditions and served as a comparison control group.

The enrichment program emphasized a stimulating environment and focused on three key elements -- nutrition, education, and physical exercise. The program was delivered daily at two specially constructed nursery schools by a specially trained staff.

Compared with controls, program participants scored lower on tests of schizophrenia-like disorders and antisocial behavior at age 17 years. They were also less likely to have a history of criminal behavior.

The strongest benefits were seen among children with evidence of malnutrition at 3 years of age.

"We caution that findings from a country that was still developing when the prevention program was conducted cannot be directly extrapolated to more developed countries such as the US," Raine's team cautions.

"Nevertheless," they write, "the findings may be particularly relevant to poor rural areas of the US...and also to US inner cities, where rates of both malnutrition and behavioral problems in children are relatively high."
 

SOURCE: American Journal of Psychiatry, September 2003.

 

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This system described below sounds like something that could be valuable in a lot of doctor's offices, mental health support group offices, and public assistance offices - I hope it gets properly funded and developed - Editor.

E-psychiatrist for quick diagnosis of Schizophrenia
 

Jennifer Foreshew
SEPTEMBER 16, 2003

DOCTORS will be able to screen for, and monitor, mental health disorders, including schizophrenia and dementia, with a system created at Queensland University, Australia.

Developed over the past 18 months by the university's Centre for Online Health, the system, known as Ex-Ray, uses speech and text to diagnose patients. Work is under way on adding imaging to the system.
 

Professor Joachim Diederich and Professor Peter Yellowlees say Ex-Ray will provide a tool as capable as an expert psychiatrist. "We not trying to pretend this is better than the psychiatrist, but we are suggesting it may be better than many primary care clinicians."

Professor Yellowlees, professor of psychiatry and director of the Centre for Online Health, said the PC-based test required a two to five minute descriptive speech and/or image sample from the patient.

The data was then analysed and classified to provide immediate analysis to assist diagnosis.

"When people with schizophrenia speak, it is not uncommon for them to be difficult to understand," Professor Yellowlees said.

"To the layperson their speech can be odd, unusual or a bit confusing."

The same was true with depression, he said. People tended to speak in a way that was "classically sad".

Ex-Ray combines a number of search engines, essentially, that are used for neural networks and other machine learning approaches.

It uses algorithms to come up with a cluster of words that are identified in particular illnesses.

In three trials, Ex-Ray delivered about 80 per cent accuracy as a screening test for both schizophrenia and depression.

The team is seeking extra funds to extend the trials.

Professor Yellowlees estimated the global market for the tool could be $2 billion annually, including the US.

The system may assist in diagnosis, screening and monitoring of a range of disorders that affect up to 16 per cent of the population, such as depression, schizophrenia, mania, dementia, delirium, drug psychoses, stroke, ataxia and a number of neurological disorders such as Parkinson's Disease.

Ex-Ray, a project of Uniquest, the university's commercial arm, recently won an award in the e-health category of the government and corporate sponsored Secrets of IT Innovation Competition 2003.

Professor Yellowlees said the team had about six months of preliminary experiments, at a cost of $300,000, to complete, and another two years of detailed commercial development at $2 million.

"If we got substantial funding tomorrow we could get this going fairly quickly," he said.

Professor Yellowlees said the tool could allow classification to be quantified mathematically and more accurately.

RELATED LINKS
www.coh.uq.edu.au
 

 

Source: Australian IT News
http://australianit.news.com.au/articles/0,7204,7276476%5E15345%5E%5Enbv%5E15306-15316,00.html

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Late-onset schizophrenia can lead to dementia

Last Updated: 2003-09-29 16:31:55 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Many individuals who develop symptoms of schizophrenia when they are 50 years of age or older exhibit a rapid decline into dementia, Australian investigators report.

However, the symptoms of older schizophrenic patients who do not develop this rapid decline in their mental capacities, actually improve over time, Dr. Henry Brodaty of Prince of Wales Hospital, Sydney, and colleagues report in the British Journal of Psychiatry.

Schizophrenia is a severe brain disorder that alters a person's emotions, thought processes and perceptions of reality. Symptoms can include apathy, hallucinations and delusions.

Most of the time, symptoms of the disorder surface during the late teens and 20s. And while most patients with schizophrenia have some difficulty with memory and intellectual functioning, these mental deficits are usually stable over time.

A small proportion of patients with schizophrenia don't develop symptoms until late adulthood, and this type of schizophrenia is not as well understood as the typical form.

Brodaty and colleagues studied 27 patients with late-onset schizophrenia and 34 healthy subjects. Average age of both groups was around 70 years. During the first year of the study, there was no evidence of cognitive decline in either group.

But after five years, approximately half of the schizophrenic patients, and none of the control subjects, had been diagnosed with dementia. Five of the 19 schizophrenic individuals who were still in the study were diagnosed with Alzheimer's disease, one with dementia due to strokes in the brain, and three with other kinds of dementia.

Brodaty's team also found good news in their data: Among individuals who did not develop dementia, their schizophrenia seemed to resolve at least partially, sometimes altogether, after five years.

The group hopes to find out why some late-onset schizophrenia patients decline so rapidly by looking at possible genetic causes, conducting more neuropsychiatric testing, and looking at patients' brain scans.

SOURCE: British Journal of Psychiatry, September 2003.

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This story has been adapted from a news release issued by Medical College Of Georgia.

 

FDA Seeks Diabetes Warning on Anti-Psychotic Drugs
By Ransdell Pierson

NEW YORK (Reuters) - U.S. regulators have requested that six of the most widely used anti-psychotic drugs carry a warning that they can increase the risk of elevated blood sugar and diabetes, Eli Lilly and Co. said on Wednesday.

Indianapolis-based Lilly, which makes the top-selling schizophrenia treatment Zyprexa, said the U.S. Food and Drug Administration (news - web sites) is also seeking the warning on the product labeling for Johnson & Johnson's rival Risperdal, Novartis AG's Clozaril, Bristol-Myers Squibb Co.'s Abilify, AstraZeneca Plc's Seroquel and Pfizer Inc.'s Geodon.

Lilly, which received a letter from the FDA on Monday, said more research is needed into the possible link.

All six of the drugs are so-called atypical anti-psychotics, a newer generation of medicines that do not cause some of the troublesome side effects, such as tremors, seen in older treatments.

FDA spokeswoman Susan Cruzan confirmed the agency had asked makers of atypical anti-psychotics to add the new warning. She said epidemiological studies suggested a link between treatment with the drugs and an increased risk of diabetes.

Analysts have speculated the FDA might require the diabetes warning for some or all of the atypical drugs, following results last month of a long-awaited study that linked three of the medicines to higher incidence of the disease.

The study, involving almost 20,000 schizophrenia patients treated at veterans' hospitals and clinics across the United States, showed patients taking Seroquel had 3.34 times as many cases of diabetes as those on older drugs.

With Risperdal, the rate was 1.49 times, or 49 percent, greater than that of the older drugs. Patients on Zyprexa were 1.27 times more likely to become diabetic.

The veterans study erased much of the stigma from Zyprexa, whose U.S. sales have slowed in the past year because it tends to cause more weight gain among patients than other atypicals.

Because obesity is a leading cause of Type II diabetes, many doctors and industry analysts had wrongly assumed Zyprexa posed the greatest diabetes risk to patients.

"The new label warning will have very limited impact on sales of any of the atypical drugs because doctors are already very familiar with their link to diabetes," said Sena Lund, an analyst with Cathay Financial LLC.

"Doctors will focus on the effectiveness of these drugs instead of diabetes risk," said Lund, who predicted few doctors would switch to older drugs because they are less effective than the atypicals.

Concerns about Zyprexa have played mostly into the hands of Bristol-Myers, whose recently launched Abilify does not cause significant weight gain among schizophrenics -- a population that is already at high risk of developing Type II diabetes.
 

 

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New Movie Review: Man's descent into schizophrenia avoids cinematic stereotype

09/25/03

John Petkovic
Plain Dealer Reporter

Films about schizophrenia always seem to take on one of two personalities.

There's the sentimental drama about mental illness - the one where never-ending compassion leads to a happy ending. Then there's the other extreme: A "mad man" goes on a rampage loaded with "deranged" dialogue and twisted faces.

Then there's "Revolution #9."

Tim McCann's portrait of a young man's descent is a film in search of a personality. Will it end happily? Violently? Hopeful or hopeless? You never really know, but that's what makes it such an engaging journey.

The film follows James (Michael Risley), a 27-year-old Manhattan apartment dweller. He's smart, handsome and successful - on the surface. Inside, Jackson is a tumultuous soul who believes that he's being controlled and manipulated by the media.

That might sound heavy-handed. At times, it is. But McCann is deft at mixing obsessive camera work like that of Roman Polanski with the detached cyber-angst of David Cronenberg to make it work.

James' trigger is a TV ad for a perfume called "Rev 9." Most would write it off as a just another pretentious perfume commercial that mixes sex with camera gimmicks and abstract gibberish to sell a potion.

Not Jackson. He sees it as a much more insidious form of mind control. So much so that he poses as a journalist and tracks down the director of the spot. It leads to a confrontation, er, I mean, an "interview," as well as the film's most warped scene.

Spalding Gray is impeccable as the pompous director who compares his "personal vision" to the cinema of Italian art-house director Michelangelo Antonioni. James wants none of it. He wants to know, "What do MTV and the Roman Empire have in common?"

It would be funny if the rest of "Revolution #9" wasn't so realistic.

Over the course of nine numbered scenes, James' inner turmoil not only bubbles out but consumes his fiancee, Kim (Adrienne Shelly). She tries to get him help at every twist and turn, only to run into one hurdle after another - their families, a bureaucratic mental-heath system and a cold, cold world that refuses to understand.

How do you relate to someone suffering from such a disease? Where do you go to get them help? How do you get through to the other side?

"Revolution #9" doesn't provide answers. But it explores the problem with the kind of nuance we rarely see on the screen.

For more information on the movie:

http://movies.yahoo.com/shop?d=hv&id=1808442823&cf=info&intl=us

http://www.trashcity.org/BLITZ/BLIT0850.HTM

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PRESS RELEASE

FDA Approves ABILIFY(TM) (Aripiprazole) for Maintaining Stability in Patients With Schizophrenia (September 8, 2003)

PRINCETON, N.J. and TOKYO, Sept. 8 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY - News) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (U.S. FDA) approved a Supplemental New Drug Application (sNDA) for ABILIFY(TM) (aripiprazole) for maintaining stability in patients with schizophrenia.
"Because schizophrenia is a chronic illness that requires ongoing treatment, it is important for physicians, consumers and family members to have information regarding the longer-term use of medication," said Dr. Peter Weiden, Director of the Schizophrenia Research Program and Professor of Psychiatry, SUNY Downstate Medical Center. "These data demonstrate that ABILIFY is efficacious in the treatment of schizophrenia for up to 26 weeks. In addition, the study demonstrated there were no medically important differences between ABILIFY and placebo in several metabolic measures."

The sNDA included results from a placebo-controlled trial involving 310 inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from their antipsychotic medications and randomized to ABILIFY 15 mg/daily or placebo for up to 26 weeks of observation for relapse. In this study, patients who received ABILIFY 15mg/daily experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo; the relative risk of relapse for aripiprazole-treated patients was half that of placebo-treated patients (relative risk of relapse for aripiprazole:placebo = 0.503, p < 0.001). Physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for individual patients.

In this long-term trial, there were no medically important differences in metabolic profile between patients receiving ABILIFY and placebo in mean change from baseline in prolactin, fasting glucose, triglyceride, high-density lipoprotein (HDL, or "good" cholesterol), low-density lipoprotein (LDL, or "bad" cholesterol) and total cholesterol measurements.

Overall mean weight change in patients receiving ABILIFY over the course of the study was -1.3 kg (-2.86 lbs) compared to -0.9 kg (-1.98 lbs) in placebo-treated patients.

Overall weight change among ABILIFY-treated patients in a previously conducted 52-week trial was +1.0 kg (+2.20 lbs). When patients in this study were grouped by BMI, weight change in patients and the percentage of patients with >/=7% increase in body weight were as follows: +2.6 kg (+5.72 lbs) and 30% in patients with BMI <23; +1.4 kg (+3.08 lbs) and 19% in patients with BMI 23-27; and -1.2 kg (-2.64 lbs) and 8% in patients with BMS >27.

In previously conducted short-term (4- and 6-week) placebo-controlled trials with ABILIFY, there was no difference in the incidence of discontinuation due to adverse events between patients treated with ABILIFY (7%) and placebo (9%) or incidence of extrapyramidal syndrome (6% vs. 6%). In addition, studies showed that ABILIFY was associated with a moderate difference in sedation (11% vs. 8% for placebo), and did not cause significant QTc interval changes. The adverse events reported in the 26-week trial were generally consistent with those reported in the short-term trials, except for a higher incidence of tremor (9% ABILIFY vs. 1% placebo). In this study, the majority of these cases were of mild intensity, occurred early in therapy (...49 days) and were of limited duration (...10 days). Tremor infrequently led to discontinuation (<1%) of ABILIFY. In addition, in a long-term (52-week) active controlled study, the incidence of tremor for ABILIFY was 4.0%.

The most commonly reported adverse events associated with ABILIFY in short-term clinical trials are headache (32% vs. 25% placebo), anxiety (25% vs. 24% placebo), insomnia (24% vs. 19%), nausea (14% vs. 10% placebo), vomiting (12% vs. 7% placebo), sleepiness (11% vs. 8% placebo), lightheadedness (11% vs. 7% placebo), restlessness (10% vs. 7% placebo) and constipation (10% vs. 8% placebo).

ABILIFY, the most recently approved treatment for schizophrenia in the United States, Mexico, Brazil, Puerto Rico, Peru, El Salvador and Australia, has been prescribed for more than 200,000 people in the United States.

ABILIFY is available in 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets. ABILIFY is available by prescription only.

For more information, please see http://www.abilify.com

SOURCE: Bristol-Myers Squibb; Otsuka Pharmaceutical Co., Ltd.
 

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PRESS RELEASE

SOLVAY PHARMACEUTICALS AND LUNDBECK MOVE INTO CLINICAL PHASE III WITH JOINT SCHIZOPHRENIA TREATMENT, BIFEPRUNOX


(PRESSI.COM 09/02/2003) Solvay Pharmaceuticals and H. Lundbeck A/S today announce their joint decision to move bifeprunox into clinical phase III with immediate effect. The decision to move into phase III follows the successful completion of the joint phase II program. In December 2000 the two companies announced that they would join forces in the development and marketing of this atypical antipsychotic, bifeprunox.

Bifeprunox is a product of Solvay Pharmaceuticals' drug discovery efforts. It was formerly known under its lab code DU127090. It is a putative full spectrum atypical antipsychotic compound aimed at the treatment of both positive and negative symptoms of schizophrenia. Its mechanism of action couples a highly potent partial agonism of the dopamine D2 receptors to an additional 5HT1A receptor partial agonist effect.

A recently finalised placebo controlled dose-finding study showed bifeprunox to be efficacious and well tolerated in the treatment of patients with schizophrenia. As desired, the tolerability profile was very encouraging with no indication of weight gain, cardiovascular or extra pyramidal side effects (EPS).

Schizophrenia is a severe disabling and chronic form of psychosis that develops in approximately 1% of the population. Schizophrenia is characterised by positive, negative, affective and cognitive symptoms. Positive symptoms comprise, among others, delusions and hallucinations. The negative symptoms include social withdrawal, blunted affects and diminished capacity of speech. Affective symptoms are mainly depression and anxiety. Typical cognitive deficits are impaired attention and memory and some times disorganised speech. While currently most widely used treatments may be effective in controlling acute symptoms of schizophrenia they are all associated with a variety of side effects that negatively influence their usefulness in long-term treatment. New treatments that improve symptomatology but with reduced side effects are therefore desirable.

Solvay Pharmaceuticals global head of Research and Development, Werner Cautreels, said "new and better medicines for treating schizophrenia are really needed by psychiatrists and bifeprunox is looking very promising. We hope to be able to bring it to markets in just a few years time"

Lundbeck's Executive Vice President, Research & Development, Claus Bręstrup says "we are pleased with the smooth way this joint project is progressing between the partners, and naturally delighted that the clinical results of phase II studies encourage an immediate start of a joint phase III program".

Under the terms of the agreement between the two companies Solvay retains the marketing rights in the US, Canada, Mexico and Japan, while Lundbeck gains the marketing rights for Europe and the rest of the World. Lundbeck and Solvay will jointly market the product in Brazil and Argentina.

For further information please contact :
SOLVAY S.A. Headquarters
Martial Tardy
Corporate Press Officer
E-mail : martial.tardy@solvay.com
Internet : www.solvay.com

 

 
 

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