10007397 J Clin Psychiatry / Document Archive

Psychiatrist.com Home    Keyword Search

Close [X]

Search Our Sites

Enter search terms below (keywords, titles, authors, or subjects). Then select a category to search and press the Search button. All words are assumed to be required. To search for an exact phrase, put it in quotes. To exclude a term, precede it with a minus sign (-).

Keyword search:

Choose a category:

Choosing the appropriate category will greatly improve your chances of finding the best match.

All files at our sites: J Clin Psychiatry, Primary Care Companion, CME Institute, and MedFair

Search materials from our journals:

Abstracts from The Journal of Clinical Psychiatry, 1996–present, both regular issues and supplements

PDFs of the full text of The Journal of Clinical Psychiatry, 1996–present, both regular issues and supplements (Net Society Platinum [paid subscribers])

PDFs of the full text of The Primary Care Companion to The Journal of Clinical Psychiatry, 1999–present

Search CME offerings:

CME Institute, including CME from journals , supplements, and Web activities for instant CME credit (Net Society Gold [registered users]); also includes information about our CME program

CME activities from regular issues of The Journal of Clinical Psychiatry (Net Society Gold [registered users])

CME Supplements from The Journal of Clinical Psychiatry (Net Society Gold [registered users])

 

The article you requested is

Efficacy and Safety of Adjunctive Oral Ziprasidone for Acute Treatment of Depression in Patients With Bipolar I Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

J Clin Psychiatry 2011;72(10):1413-1422
10.4088/JCP.09m05934
Copyright 2011 Physicians Postgraduate Press, Inc.

To view this item, select one of the options below.

  1. NONSUBSCRIBERS
    1. Purchase this PDF for $30
      If you are not a paid subscriber, you may purchase the PDF.
      (You'll need the free Adobe Acrobat Reader.)
    2. Subscribe
      Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($129) or print + online ($166 individual).
    3. Celebrate JCP's 75th Anniversary with a special online-only subscription price of $75.
  2. PAID SUBSCRIBERS
    1. Activate
      If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
    2. Sign in
      As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
  1. Did you forget your password?

Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send an email

| 107.20.30.170

Objective: To assess efficacy and safety of adjunctive ziprasidone in subjects with bipolar depression treated with lithium, lamotrigine, or valproate.

Method: 298 adult outpatients with bipolar I disorder (DSM-IV criteria) were randomized to receive ziprasidone, 20–80 mg twice a day, or placebo twice a day for 6 weeks plus their preexisting mood stabilizer. The primary efficacy variable was change in Montgomery-Asberg Depression Rating Scale (MADRS) total scores from baseline to 6 weeks. The key secondary efficacy endpoint was change from baseline to week 6 in Clinical Global Impressions-Severity (CGI-S) scores. Computer-administered assessments for diagnostic confidence were included for quality control and to evaluate study performance. The study was conducted between October 2007 and December 2008.

Results: The mean ± SD daily dose of ziprasidone was 89.8 ± 29.1 mg. Least squares mean ± standard error changes from baseline to week 6 on MADRS total score for ziprasidone and placebo treatment groups were −13.2 ± 1.2 and −12.9 ± 1.1, respectively, with a 2-sided P value of .792. There was no significant difference on the key secondary variable (CGI-S). Adjunctive ziprasidone was well tolerated. Poor quality ratings at baseline were associated with a trend for better improvement on placebo than ziprasidone. Among 43 placebo-treated subjects with poor baseline quality ratings, 29 (67.4%) had baseline MADRS scores > 10 points higher on the computer-administered assessment than the MADRS administered by the site-based rater. The response favoring placebo over ziprasidone observed in this subgroup suggests that poor signal detection in some clinical trials can be a consequence of “subject inflation” as well as “rater inflation.”

Conclusions: Adjunctive ziprasidone treatment failed to separate from mood stabilizer alone on primary and secondary endpoints. Possible contributions to this result include enrollment of a substantial number of subjects with low diagnostic confidence, low quality ratings on the MADRS, and overzealous reporting of symptoms by subjects.

Trial Registration: clinical trials.gov Identifier: NCT00483548

J Clin Psychiatry

Submitted: December 22, 2009; accepted August 19, 2010.

Online ahead of print: May 3, 2011 (doi:10.4088/JCP.09m05934).

Corresponding author: Gary S. Sachs, MD, Bipolar Clinic and Research Program, Massachusetts General Hospital, 50 Staniford St, 5th Floor, Boston MA 02114 (SachsG@aol.com).