Featured Research

from universities, journals, and other organizations

Limitations of evidence base for prescribing aripiprazole in maintenance therapy of bipolar disorder

Date:
May 3, 2011
Source:
Public Library of Science
Summary:
The evidence base for the prescribing of aripiprazole in maintenance treatment of bipolar disorder is limited to a single trial, sponsored by the manufacturer of aripiprazole, according to a rigorous appraisal of the evidence for its use.

The evidence base for the prescribing of aripiprazole in maintenance treatment of bipolar disorder is limited to a single trial, sponsored by the manufacturer of aripiprazole, according to a rigorous appraisal of the evidence for its use led jointly by Alexander Tsai of Harvard University, Boston USA, and Nicholas Rosenlicht of the University of California San Francisco, USA. In the paper, published in PLoS Medicine, the authors describe key limitations of the trial, which were not identified in most subsequent review articles and guidelines for the treatment of bipolar disorder in which the trial was cited.

Bipolar disorder (also known as manic depression) is a common and serious psychiatric illness. Individuals with bipolar disorder experience mood swings with manic episodes (where they may feel euphoric, restless, and behave impulsively), along with depressive episodes where they may feel low, worthless, and suicidal. Aripiprazole is a second-generation antipsychotic medication and the newest of such drugs to have received approval by the US Food and Drug Administration (FDA) for use both in treatment of acute episodes and, more recently, for maintenance therapy.

Drs. Tsai and Rosenlicht and their colleagues conducted a systematic search to find all published and unpublished studies relating to use of aripiprazole for maintenance therapy of bipolar disorder, including a request to the FDA under Freedom of Information Act legislation. They critically appraised this evidence and then used citation searches to examine how the primary evidence was subsequently referenced in the medical literature. The authors found only a single trial describing the use of aripiprazole during the maintenance phase of bipolar disorder. Further, they found significant limitations of this trial that constrain its interpretation as supporting the use of aripiprazole for this indication. First, the trial duration was too short to show that the drug was truly helpful in maintaining initial benefit or preventing mood swings over the long term. Second, very few participants in the trial completed the entire study. Third, the trial was based on a select minority of subjects who had shown an initial response to the drug, making it difficult to extrapolate these findings to patients with bipolar disorder more widely. Fourth, the trial had a design whereby patients assigned to placebo were abruptly taken off aripiprazole treatment given to them during a previous "run-in" phase and reassigned to placebo; differences in risk of relapse seen between trial arms may thus also reflect the potentially harmful effects of rapid drug withdrawal in patients given placebo.

Despite these shortcomings, the authors found that this single trial was subsequently cited by 104 review articles and treatment guidelines, with very few mentioning the study's limitations.

The authors comment that "…alternative modifications or study designs may improve the probability of generating more useful data from studies in this vulnerable patient population to inform the treatment of similar patients in the future."

Patients (or their family members) who may learn of this study's findings are urged to contact their physician if concerned about what these findings may mean for their treatment. Specifically, the findings do not mean patients should cease their medication; despite the limitations of the evidence described here, this drug may be helpful to them. In addition, the study did not assess the evidence for the use of aripiprazole in acute treatment of bipolar disorder.


Story Source:

The above story is based on materials provided by Public Library of Science. Note: Materials may be edited for content and length.


Journal Reference:

  1. Alexander C. Tsai, Nicholas Z. Rosenlicht, Jon N. Jureidini, Peter I. Parry, Glen I. Spielmans, David Healy. Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature. PLoS Medicine, 2011; 8 (5): e1000434 DOI: 10.1371/journal.pmed.1000434

Cite This Page:

Public Library of Science. "Limitations of evidence base for prescribing aripiprazole in maintenance therapy of bipolar disorder." ScienceDaily. ScienceDaily, 3 May 2011. <www.sciencedaily.com/releases/2011/05/110503171727.htm>.
Public Library of Science. (2011, May 3). Limitations of evidence base for prescribing aripiprazole in maintenance therapy of bipolar disorder. ScienceDaily. Retrieved July 29, 2014 from www.sciencedaily.com/releases/2011/05/110503171727.htm
Public Library of Science. "Limitations of evidence base for prescribing aripiprazole in maintenance therapy of bipolar disorder." ScienceDaily. www.sciencedaily.com/releases/2011/05/110503171727.htm (accessed July 29, 2014).

Share This




More Mind & Brain News

Tuesday, July 29, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Losing Sleep Leaves You Vulnerable To 'False Memories'

Losing Sleep Leaves You Vulnerable To 'False Memories'

Newsy (July 27, 2014) A new study shows sleep deprivation can make it harder for people to remember specific details of an event. Video provided by Newsy
Powered by NewsLook.com
University Quiz Implies Atheists Are Smarter Than Christians

University Quiz Implies Atheists Are Smarter Than Christians

Newsy (July 25, 2014) An online quiz from a required course at Ohio State is making waves for suggesting atheists are inherently smarter than Christians. Video provided by Newsy
Powered by NewsLook.com
Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

AFP (July 24, 2014) A so-called drugs rehab 'clinic' is closed down in Pakistan after police find scores of ‘patients’ chained up alleging serial abuse. Duration 03:05 Video provided by AFP
Powered by NewsLook.com
New Painkiller Designed To Discourage Abuse: Will It Work?

New Painkiller Designed To Discourage Abuse: Will It Work?

Newsy (July 24, 2014) The FDA approved Targiniq ER on Wednesday, a painkiller designed to keep users from abusing it. Like any new medication, however, it has doubters. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins