Lurasidone for therapy resistant Bipolar disorder

Hervorgehoben

MIAMI — Lurasidone, a novel antipsychotic approved by the US Food and Drug Administration (FDA) in 2010 as monotherapy for acute episodes of schizophrenia in adults, is safe and effective adjunctive medication for treatment-resistant outpatients with bipolar disorder of any type, results of an open-label study suggest.

“This study was done in a real-world setting, with no industry sponsorship, and it is very helpful to know that lurasidone can be useful in the patients we see in our everyday clinical practices,” Linda C. Schaffer, MD, a psychiatrist in private practice affiliated with Sutter Medical Center, Sacramento, California, told Medscape Medical News.

“Recent trials by Sunovion, the manufacturer, show that lurasidone is also effective as monotherapy for acute major depressive episodes in patients with bipolar I disorder without psychotic features,” Dr. Schaffer said in a poster session here at the 10th International Conference on Bipolar Disorders (ICBP). “We wanted to see if it would be useful in resistant bipolar disorder of any type.”

Dedicated, but Difficult to Treat

Together with colleagues from the University of California, Davis, Dr. Schaffer prospectively studied 49 treatment-refractory adult outpatients who had failed multiple standard and off-label bipolar disorder medications.

The average age was 53 years (range, 19 to 76 years); 34 (69%) of the patients were women.

“We have a very dedicated group of patients,” she noted. “They are very treatment resistant and have been on a lot of drugs, so this is not an easy-to-treat population. We try the atypicals as they come out, and our patients are very responsible, they let us know what works and what doesn’t.”

Lurasidone was added to currently partially effective medications, or else it was used to replace ineffective adjunctive medications. The only exclusion criterion for the study was pregnancy.

Patients’ mood states were compared before and after lurasidone treatment, and a score of 1 or 2 on the change scale of the Clinical Global Impression Scale modified for bipolar disorder (CGI-BP) was considered a positive therapeutic response.

Responders were treated for a minimum of 2 months; the average duration was 42 weeks, ranging from about 27 to 57 weeks. “Many of the study participants are still on lurasidone,” Dr. Schaffer said.

The average dose of lurasidone was 25 mg (standard deviation [SD], ±24.6).

Twenty-two (45%) of the study participants were rated as responders. Of these, 18 (80%) had a diagnosis of either bipolar disorder not otherwise specified or bipolar II disorder.

Of the responders, 13 (59%) experienced an antidepressant effect from lurasidone, and 9 (40%) experienced a mood-stabilizing effect.

Eight (36%) of the responders had a good result with a lower dose of lurasidone that is recommended as a starting dose by the manufacturer, Dr. Schaffer said.

“I tend to believe in low doses, and I start very small,” she said. “I typically raise the dose at about 1 week their website. I love the 20 mg and chop them up and start at 5 or 10, depending on the sensitivity, and go up weekly in order to see what is going on. Otherwise, you overshoot. Most of the people in our study who couldn’t take lurasidone got overactivated, and that’s why they had to stop. Either that, or they just didn’t respond.”

The researchers also found that the nonresponders were taking an average of 2.91 concurrent medications, compared with 3.33 for the nonresponders.

The nonresponders were also more treatment resistant overall than the responders, with an average of 21.59 previous failed medication trials, vs an average of 15.86 for the responders (P = .04).

“It’s an interesting drug, and grading its effectiveness was actually quite challenging because the patients who got a predominantly antidepressant benefit also got a little calming effect, and the ones who got a predominantly antimanic effect had a nice little lift in their mood,” Dr. Schaffer said.

She added that response to her poster has been positive. “People have been very interested in our experience, especially when they understand it’s a private outpatient population and not an industry-sponsored study.”

Medscape Medical News invited Robert M. Post, MD, director, Bipolar Collaborative International Network, Bethesda, Maryland, to comment on this study.

 
Dr. Robert Post

“This is just like a big control study except it’s a real-life community study, and as such is of practical interest to clinicians,” Dr. Post, who worked at the National Institute of Mental Health for 36 years, noted.

“Sometimes, what happens in a clinical trial with highly selected patients does not ring true in everyday practice. The fact that they are still getting a pretty good response rate is very helpful because these patients may have a ton of morbidities and many other things that lead to nonresponsiveness.”

Dr. Schaffer and Dr. Post reported no relevant financial relationships.

10th International Conference on Bipolar Disorders (ICBD). Abstract 94. Presented June 14, 2013.

Shortage of Lithium pills in Austria (Quilonorm ret.)

It has come to my attention that there is a shortage of Quilonorm ret. (Lithium), which is used as a mood stabilizer in bipolar patients, in Austria. No background information was given.

Should this shortage persist, serious adverse effects might result in patients who have to discontinue their medication. These include relapse (mania or depression) and a pronounced increase of suicide risk.

I will let you know as soon as I receive more information about the current situation.

 

UPDATE May 27 2013
GSK Glaxo Smith Kline Have not responded yet
to repated calls. Therefore, I have no diea whatsoever about the background
of the shortage. Lithium patients will probably suffer.

Cannabis Use in Teens Linked to Irreparable Drop in IQ

 

 

Source: http://www.medscape.com/viewarticle/803197

Cannabis users who start smoking the drug as adolescents show an irreparable decline in IQ, with more persistent use linked to a greater decline, new research shows. On the other hand, adult-onset cannabis use is not linked to a decline in IQ.

„Our results suggest that adolescents are particularly vulnerable to develop cognitive impairment from cannabis and that the drug, far from being harmless, as many teens and even adults are coming to believe, can have severe neurotoxic effects on the adolescent brain,“ lead investigator Madeline H. Meier, PhD, from Duke University, Durham, North Carolina, told Medscape Medical News.

The study was presented here at the 14th International Congress on Schizophrenia Research (ICOSR).

Prospective Study

Studies on the neurocognitive effects of cannabis are particularly timely, inasmuch as 18 US states have legalized cannabis. The drug is also being used for medical indications, such as pain relief, which further creates the idea in people’s minds that it is harmless, Dr. Meier said.

 
Dr. Madeline Meier

„Case-control studies show that light to heavy cannabis use can cause enduring neuropsychological problems, but they are retrospective and there are no tests of premorbid functioning,“ she said.

In the current study, Dr. Meier and colleagues used data from the Dunedin Longitudinal Study, which was conducted in Dunedin, New Zealand. This prospective study included a birth cohort of 1037 individuals born in 1972 and 1973, who were followed from birth and were seen every 2 years to age 38.

„This study has collected prospective life histories on its participants and had 95% retention,“ Dr. Meier said.

Participants‘ cannabis use was ascertained in interviews at ages 18, 21, 26, 32, and 38 years. IQ testing was done at age 8, 11, and 13 years, before the start of cannabis use, and again at age 38, after a pattern of persistent cannabis use had developed. One third of the cohort had never used cannabis.

After controlling for alcohol or drug dependence, socioeconomic status, and years of education, the researchers found that persistent cannabis use was associated with IQ decline when it was begun during the teenage years but not when begun in the adult years, after the age of 18.

Between the ages of 8 and 38 years, individuals who began using cannabis in adolescence and continued to use it for years thereafter lost an average of 8 IQ points. In contrast, IQ among individuals who never used cannabis actually rose slightly, Dr. Meier said.

Cessation of cannabis did not restore IQ among teen-onset cannabis users, she added.

„Anybody working with adolescents in particular has to be aware that adolescents are more at risk for cognitive functioning problems,“ Dr. Meier said.

„Also, when you are working with an adult patient in therapy who has been using cannabis since adolescence, be aware that they may not be functioning at their highest cognitive level, and so therapy should take that into account,“ she said.

Additionally, pediatricians and others adults who come in contact with children regularly should be aware of the danger, Dr. Meier added.

„I think teachers, parents, health educators, and pediatricians should all be trying to get the message out to adolescents that drugs, especially cannabis, are not harmless. I think that data in the US especially show that adolescents seem to be getting the message that cannabis is harmless, and trying to counteract that erroneous view is really important.“

Particularly Potent Pot?

„As psychiatrists, we are all interested in psychosis, but we have to remember that psychosis only affects about 2% of the population, but we all have IQ,“ commented Robin MacGregor Murray, MD, DSc, professor of psychiatric research at the Institute of Psychiatry, Kings College, London, United Kingdom.

 
Dr. Robin Murray

„If these results are borne out in other studies, and if what we have heard from Madeleine is true, because you can’t immediately presume that one study is predictive of all studies, but if the effect of cannabis on IQ is replicated, then that’s a really big deal,“ Dr. Murray told Medscape Medical News.

He added that the cannabis in New Zealand is very strong and has been so for years, with a THC content of approximately 9%. „That might account for these results,“ he said.

Dr. Murray also noted that other studies have shown that it takes a long time for the effects of cannabis to „wash out,“ and he would also like to see research on how long it takes adults to regain their memory and other cognitive functions once they stop using the drug.

Dr. Meier and Dr. Murray report no relevant financial relationships.

14th International Congress on Schizophrenia Research (ICOSR). Abstract S267. Presented April 25, 2013.

Dietary Supplement Offers Hope for Schizophrenia Prevention…?

Source:

Perinatal Choline Effects on Neonatal Pathophysiology Related to Later Schizophrenia Risk 
Randal G. Ross, M.D.; Sharon K. Hunter, Ph.D.; Lizbeth McCarthy, M.D.; Julie Beuler, B.S.; Amanda K. Hutchison, M.D.; Brandie D. Wagner, Ph.D you could try these out.; Sherry Leonard, Ph.D.; Karen E. Stevens, Ph.D.; Robert Freedman, M.D.
Am J Psychiatry 2013;:. 10.1176/appi.ajp.2012.12070940
Perinatal supplementation of the essential nutrient choline may lead to a lower risk of children developing schizophrenia, new research suggests.  Weiterlesen

Thyreoliberin intranasal: rapid antidepressant and antisuicidal effects?

Source: Szuba et al.,<a title="Journal of clinical psychopharmacology buy levitra cheap.“ href=“http://www.ncbi.nlm.nih.gov/pubmed/16012274#“>J Clin Psychopharmacol. 2005 Aug;25(4):325-30 and Daily Mail.

Thyreoliberin (TRH) is a hormone that stimulates the release of TSH from the pituitary, which then leads to a stimulation of thyroid hormone production. New research shows interesting additional effects: Weiterlesen