Schizophrenia discovery opens path to new treatments

Schizophrenia has been linked to a split protein, opening a path to a new class of treatments for the common mental illness.
Pregnancy stress linked to child schizophrenia
Hope for new schizophrenia drugs
Schizophrenia genes blessed by evolution

It was once thought - wrongly - that sufferers have a "split personality" but now, researchers at the Flanders Institute for Biotechnology, VIB, and University of Leuven have discovered that faulty snipping of a protein called neuregulin, or Nrg-1, lies at the basis of the development of the disease.

Greater understanding of this molecular process is a first step toward improved diagnosis of the one in 100 people who suffer from the delusions, hallucinations and disturbed thinking and more effective treatment of schizophrenia and other related disorders.

Up to now, no clear cause of schizophrenia has been found, although hereditary factors certainly play a role along with living and working conditions, with the condition being more common in urban dwellers and younger people.

However, previous scientific studies have suggested that faulty functioning of the Nrg-1 protein plays a role.

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Politics In The Suicide Black Box Decision For Bipolar, Epilepsy Meds

As some of you know, yesterday the FDA's psychopharmacology advisory committee declined to approve the FDA's recommendation that a black box warning be added to 11 anti-seizure drugs used to treat bipolar disorder and epilepsy. I've not seen a lot of press on the decision yet, so the committee's reasoning is not clear to me, but you can glean a bit from this early piece by the Dow Jones News Service:

"Panel members raised concerns about the unintended consequences of adding a black-box warnings to epilepsy [drugs], saying such a move would make doctors wary of prescribing the drugs.

"Panel member Sean Hennessy, a doctor, said he thinks there should be an additional warning on epilepsy drug labels, but added the FDA's analysis shows suicidal risks are 'modest.'

"'To me (the data) says there ought to be a warning, but given what we know about the effects on prescribing, I don't know if they rise to the level of a black box,' Hennessy said.

"GlaxoSmithKline Plc's (GSK) Jack Modell, vice president of clinical development, said his company believes additional warnings should be included on the label. An FDA analysis showed that Glaxo's epilepsy drug Lamictal had a higher increased risk of suicidal behavior and suicidal thoughts than other drugs."

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Do Antidepressants Make Bones Brittle?

Older adults may get a needed mood boost from a prescribed antidepressant, but they're also at increased risk for bone fractures, a growing number of studies suggest.

In one of the latest reports, Leslie Spangler, a researcher at Group Health, a Seattle-based health plan, found that antidepressant use in postmenopausal women, who averaged 64 years of age, was linked to an increased risk of fractures of the spine and other sites.

"Our study didn't show any strong association between antidepressants and wrist fractures and hip fractures," she said. "It did find an association with spine fracture."

Those women on antidepressants had a 30 percent increased risk of spine fracture, she said, and a 20 percent increased risk of any type of fracture.

Spangler's team based its findings on a review of data from more than 93,000 women enrolled in the large Women's Health Initiative Observational Study. First, the researchers looked at antidepressant use, then they looked at the incidence of fractures. The findings were published in the May issue of theJournal of General Internal Medicine.

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Psychiatric Group Faces Scrutiny Over Drug Industry Ties

It seemed an ideal marriage, a scientific partnership that would attack mental illness from all sides. Psychiatrists would bring to the union their expertise and clinical experience, drug makers would provide their products and the money to run rigorous studies, and patients would get better medications, faster.

But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing.

The association is the voice of establishment psychiatry, publishing the field’s major journals and its standard diagnostic manual.

“I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Mr. Grassley said Thursday in a letter to the association.

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Risks of Suicidal Ideation and Behavior with Epilepsy Drugs Reaffirmed

All epilepsy drugs should carry a warning -- not necessarily boxed -- about increased risks for suicidal ideation and behavior, a joint meeting of two FDA committees concluded here.

In January, the FDA released results of an analysis that found almost double the risk of suicidality with the use of 11 drugs used to treat epilepsy or psychiatric conditions. (See: FDA Finds Suicidal Behavior in Studies of 11 Epilepsy Drugs)

Today, a joint meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee voted overwhelmingly in favor of the agency's conclusions that the finding of increased risk should apply not only to all of the drugs in the analysis, but to all anticonvulsants currently on the market.

The committees also voted to describe the risks in a medication guide that would be handed out to patients who were prescribed the drugs.

However, the idea of including a black box warning on the drugs was rejected. Committee members feared that such a warning would discourage physicians from appropriately prescribing the drugs to those who need them.

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Abuses Are Found in Online Sales of Medication

A large majority of 365 Internet sites that advertise or sell controlled medications by mail are offering to supply the drugs without a proper prescription, according to a new study. The online trade is stoking the rising abuse of addictive and dangerous prescription drugs, the authors and federal officials say.

Drugs offered online include generic versions of opiates like OxyContin, methadone and Vicodin, which are legitimately prescribed as painkillers; benzodiazepines like Xanax and Valium, which are prescribed for anxiety; and stimulants like Ritalin.

Federal and state efforts to crack down on Internet sales appear to have reduced the number of sites offering such drugs, from 581 last year, said Joseph A. Califano Jr., director of the National Center on Addiction and Substance Abuse at Columbia University.

“Nevertheless, anyone of any age can obtain dangerous and addictive prescription drugs with the click of a mouse,” Mr. Califano said. The center is issuing the study, the latest of five annual surveys, on Wednesday.

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Some Antidepressants Associated With Gastrointestinal Bleeding

A class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) appear to be associated with bleeding in the upper gastrointestinal tract, according to a new article. The effects appear increased when antidepressants are combined with other stomach-harming medications and decreased when acid-suppressing agents are used.

Since the early 1990s, case reports have suggested an association between SSRIs and bleeding in the upper gastrointestinal (GI) tract, according to background information in the article. "The wide use of this drug class requires research to provide more accurate risk estimates, to identify factors that may further increase the risk and, in particular, to determine whether using acid-suppressing agents may reduce the risk," the authors write. "It is also important to determine whether venlafaxine hydrochloride, a new antidepressant related to SSRIs, also increases the risk of bleeding, as some individual case reports have suggested."

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Some Antidepressants Work Quickly

pillsA single antidepressant tablet makes a depressed person see the world in a more positive light just four hours after swallowing it, suggests a new study.

Dr Philip Cowen, professor of pharmacology at the Department of Psychiatry at the University of Oxford, told delegates at the Royal College of Psychiatrists’ Annual Meeting in London that antidepressant medication starts to work far faster than most clinicians assume.

“Depressed people interpret the world in a negative way,” he said. “They become stuck in this state. Negativity causes depression and depression causes negativity and, whatever happens, events will be interpreted in a negative way.”

Antidepressants elevate mood, which in turn leads to a depressed person becoming more positive and interpreting things that happen to them in a positive way. Prof Cowen said: “Antidepressants change biases. People who take them begin to see the world in a positive light,” said Prof Cowen

But it does not take weeks for this change to happen. Prof Cowen and his colleagues gave 30 depressed people one single 4mg dose of reboxetine – which inhibits the update of both serotonin and noradrenaline in the brain – and compared them with 30 ‘controls’ who were given a placebo or dummy pil

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Head fake - How Prozac sent the science of depression in the wrong direction

PROZAC IS ONE of the most successful drugs of all time. Since its introduction as an antidepressant more than 20 years ago, Prozac has been prescribed to more than 54 million people around the world, and prevented untold amounts of suffering.

But the success of Prozac hasn't simply transformed the treatment of depression: it has also transformed the science of depression. For decades, researchers struggled to identify the underlying cause of depression, and patients were forced to endure a series of ineffective treatments. But then came Prozac. Like many other antidepressants, Prozac increases the brain's supply of serotonin, a neurotransmitter. The drug's effectiveness inspired an elegant theory, known as the chemical hypothesis: Sadness is simply a lack of chemical happiness. The little blue pills cheer us up because they give the brain what it has been missing.

There's only one problem with this theory of depression: it's almost certainly wrong, or at the very least woefully incomplete. Experiments have since shown that lowering people's serotonin levels does not make them depressed, nor does it does not make them depressed, nor does it worsen their symptoms if they are already depressed.

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Ritalin-style Drug Set For Wider Role In Adult Mental Illness

A significant number of adults with unresolved depression, anxiety or addiction may actually have Attention Deficit Hyperactivity Disorder (ADHD), a condition that has been widely considered to resolve in late adolescence.

Armed with the correct diagnosis, adult ADHD sufferers could soon be prescribed Ritalin-style stimulant medications for a range of mental health problems that are not usually associated with the disorder, the Royal College of Psychiatrists' annual meeting was told on Friday 4 July.

Stimulant medication is currently only licensed for children with ADHD. However, the National Institute for Health and Clinical Excellence (NICE) is expected to recommend that this class of drug can be prescribed adults with ADHD in September 2008 - following the recognition that the condition persists into adulthood in about 20 per cent of cases diagnosed in childhood.

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New Depression Treatment For Cancer Patients Shows Promise

An article published in The Lancet finds that cancer patients who received a care package called "Depression Care for People with Cancer" (DCPC) had lower levels of depression than those who received the usual care (antidepressants and mental health services recommended by the cancer team). Professor Michael Sharpe (University of Edinburgh, UK) and other colleagues who study psychological medicine also found that as a way of improving the quality of life of cancer patients, DCPC is more cost-effective than the current cancer treatments.

It is not uncommon for patients suffering from disorders such as cancer to experience major depression - a condition that sharply reduces quality of life. The medical community, however, lacks substantial research that can assist physicians in helping patients manage depression. In order to add to this scarce body of evidence, Sharpe and colleagues conducted the SMaRT (Symptoms Management Research Trials) oncology 1 trial to study this new complex care package (DCPC) specially designed for cancer patients with depression and delivered by nurses.

Funded by Cancer Research UK, the trial consisted of 200 patients - all with a cancer prognosis of more than six months and major depression - selected from a regional cancer center in Scotland. The patients were about 56.6 years, on average, and 71% were women (141 of 200). In the randomization process, 99 patients were placed in a group that received the usual care of antidepressants and mental health referrals that depressed cancer patients receive from their general practitioner and cancer team. The other 101 patients were placed in a group that received the usual care in addition to DCPC.

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Antidepressants: Weighing the Decision

It's almost the definition of a good mother: someone who puts her child's welfare ahead of her own. So women may agonize if they are pregnant and must decide whether to accept a treatment that could help them but harm their fetus. As many as 20 percent of pregnant women experience significant depression. Stopping antidepressant medication during pregnancy may increase the risk of relapse for the mom, but some drugs may hold dangers for the fetus. What's a mother to do?

The answer is to focus on the right issues. Just as no medical treatment is without risk or potential discomfort, doing nothing also carries risks and discomforts. Try not to overreact to scary news accounts; instead, look at your own situation carefully. Since the sources of depression are very varied, learn as much as you can about the nature of your depression. For example, depression varies in intensity and may disturb sleep or appetite, or interfere with functioning. Mood may be constantly mildly low, or there may be shorter, more severe episodes with relatively normal periods in between. Any amount of distress is worth reporting to your doctor.

Data from decades of research on treatment are reassuring. Until recently, most data have shown that exposing a fetus to antidepressants has not increased the risk of birth defects. The FDA did circulate a warning recently about the drug paroxetine but is still studying it and has not yet issued a final recommendation.


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FDA Approves First Generic Risperidone to Treat Psychiatric Conditions

The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.

Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.

The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.

from FDA NEWS

Old Schizophrenia Drug Fights Violence as Effectively as Second-Generation Antipsychotics

The newer, atypical antipsychotics were no better than a first-generation agent in reducing violent behavior in schizophrenic patients, researchers here said.

Among 1,445 patients randomly assigned to one of five antipsychotic drugs, the overall proportion showing violent behavior declined from 19% at baseline to 14% after six months on an intent-to-treat basis, with no differences seen between different medications, reported Marvin Swartz, M.D., of Duke University, and colleagues in the July 1 issue of the British Journal of Psychiatry.

They conducted a new analysis of data from the initial randomization phase of the prospective, double-blind Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project, a multi-center trial comparing the effectiveness of different drugs for schizophrenia.

"Contrary to high expectations and some previous research, this study did not show an advantage for second-generation antipsychotics in violence risk reduction when compared with perphenazine, a representative first-generation antipsychotic," the researchers wrote.

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Mental illness must be taken from the shadows

In the 19th century England, mental health issues were governed by what was known as 'lunacy law'. Although Victorian parliamentary acts changed the status of those suffering from mental illness from prisoners to patients, they were still kept in brutal asylums.

Today, modern medicine has a sophisticated understanding of the broad spectrum of disorders that constitute mental illness, but politics seem scarcely to have moved on. Mental health treatment is in crisis. Acute psychiatric wards are 'not safe' and are 'uninhabitable', according to Dinesh Bhugra, the new president of the Royal College of Psychiatrists, whose damning verdict is reported in today's Observer. Patients are neglected and often put at risk of violence and sexual assault. The problem, as it has been for decades, is a woeful lack of funding compounded by ministerial failure to address the needs of mental health patients.

Nine years ago, the government cited transforming treatment of mental illness along with heart disease and cancer as one of its top three priorities for the NHS. Since then, the only substantial change has been the Mental Health Act 2007, which strengthened the regime under which people can be forced to accept medication and be 'sectioned' - detained on wards against their will. Those wards were described earlier this year by the Mental Health Commission as having become 'tougher and scarier' places in the last decade. In other words, the most vulnerable and disorientated people are sent to a place likely to exacerbate depression and psychosis.

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Dementia linked to low childhood intelligence

Researchers have found a link between dementia and childhood intelligence.

A study by doctors from the University of Edinburgh found the risk of vascular dementia – caused by problems in blood supply in the brain – increased in cases of lower childhood IQ.

The results also showed a cut in smoking and attempts to lower blood pressure early in life could help people with lower IQs reduce the risk of developing the brain disease.

Part of the study compared medical records of 173 people randomly selected from the Scottish Mental Survey of 1932 – a mental ability test of most 11-year-olds at schoolinScotland.

Dr Brian McGurn, lead researcher, said: “We have shown that for people with lower mental ability in early life there seems to be a higher risk of vascular dementia in later life. The unique data available from the Scottish Mental Survey means the link can be demonstrated independently of factors like socio-economic status and education.”

Vascular dementia is the second most common form of dementia after Alzheimer’s and has been linked to high blood pressure, high cholesterol and smoking. In the UK there are about 112,000 sufferers.

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ADHD Gene Doesn't Predict Response to Drugs

Canadian researchers report that their discovery of a gene variant that seems to affect the severity of attention-deficit hyperactivity disorder did not help them predict which patients are likely to respond to a class of drugs widely used to treat the disorder.

The lack of a connection between the variant and response to methylphenidates was a blow for researchers, who have hoped to use genetic data to better predict who might be the best candidates for this treatment. Ritalin is one example of a methylphenidate.

"It is a negative study," said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Schneider Children's Hospital in New Hyde Park, N.Y. "The goal is to try and better identify patients who are best going to respond to which medicine, and they didn't get the findings they were hoping to find. Their theory wasn't supported by the data."

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DEA seeks new restrictions on Internet pharmacies

Illicit Internet pharmacies are helping abusers obtain controlled drugs such as the anti-anxiety medication Xanax, the painkiller Vicodin and anabolic steroids, the Drug Enforcement Administration told a House subcommittee on Tuesday.

The DEA wants Congress to require that drugs be sold over the Internet only on the basis of "valid prescriptions" that are written after face-to-face medical evaluations or, under special circumstances, through telemedicine.

Patrick Egan, a Philadelphia lawyer who specializes in Internet pharmacy regulations, countered that the DEA's proposed requirements would impose a hardship on rural and poor patients who use Internet pharmacies to reduce prescription drug costs. Telemedicine might solve part of the problem, he said, but not for patients who can't afford a consultation.

Other witnesses before the House Subcommittee on Crime, Terrorism and Homeland Security said that federal regulation of Internet drug sites is needed. State regulations vary widely, said William Winsley, the executive director of the Ohio State Board of Pharmacy, and illicit Internet drug site operators seek out the least regulated ones.

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House Votes to Expand Civil Rights for Disabled

The House passed a major civil rights bill on Wednesday that would expand protections for people with disabilities and overturn several Supreme Court decisions issued in the last decade.

The bill, approved 402 to 17, would make it easier for workers to prove discrimination. It would explicitly relax some stringent standards set by the court and says that disability is to be “construed broadly,” to cover more physical and mental impairments.

Supporters of the proposal said it would restore the broad protections that Congress meant to establish when it passed the Americans With Disabilities Act that President George Bush signed in 1990.

Lawmakers said Wednesday that people with epilepsy, diabetes, cancer, cerebral palsy, multiple sclerosis and other ailments had been improperly denied protection because their conditions could be controlled by medication or were in remission. In a Texas case, for example, a federal judge said a worker with epilepsy could not be considered disabled because he was taking medications that reduced the frequency of seizures.

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Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference

Results from olanzapine )long-acting injection (LAI) clinical trials showed that the efficacy and safety profile of olanzapine LAI was generally consistent with that of Zyprexa(R) (olanzapine) with the exception of injection-related events. Results from a 24-week maintenance study (HGKA) and interim findings from an ongoing open-label study (HGKB) were presented at the first annual Schizophrenia International Research Society (SIRS) Conference in Venice, Italy.

Olanzapine LAI is an investigational formulation that combines olanzapine with a pamoate salt, resulting in an extended delivery of up to four weeks. Since olanzapine was introduced in 1996, it has been prescribed to approximately 24 million people worldwide.

"These studies offer insight into the potential of olanzapine LAI as a maintenance treatment for patients with schizophrenia who may have difficulty taking medication on a daily basis," said David McDonnell, M.D., clinical research physician at Lilly. "Schizophrenia is a challenging and complex disease to manage, which is why finding new ways to support patient compliance with medication is so important."

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