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Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

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ClinicalTrials.gov Identifier: NCT00483548
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : February 23, 2010
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 5, 2007
First Posted Date  ICMJE June 7, 2007
Results First Submitted Date  ICMJE December 22, 2009
Results First Posted Date  ICMJE February 23, 2010
Last Update Posted Date February 23, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Week 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
Change in the total MADRS score (depression rating scale) from Baseline to Week 6
Change History Complete list of historical versions of study NCT00483548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S) [ Time Frame: Baseline, Week 6 ]
  • MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6 [ Time Frame: Week 6 ]
  • MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6 [ Time Frame: Week 6 ]
  • Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6 [ Time Frame: Baseline, Week 6 ]
  • Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6) [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 ]
  • Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6) [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 ]
  • CGI-Improvement Score [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]
  • Change From Baseline in Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
  • Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6 [ Time Frame: Baseline, Week 6 ]
  • Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3) [ Time Frame: Baseline, Week 6 ]
  • Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5) [ Time Frame: Baseline, Week 6 ]
  • Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6 [ Time Frame: Baseline, Week 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
  • Change from Baseline to Week 6 in CGI-S (global evaluation of severity)
  • MADRS Remission Rate at Week 6
  • MADRS Response Rate at Week 6
  • CGI-I (global evaluation of improvement) Response Rate at Week 6
  • Change in MADRS, CGI-S, CGI-I, HAM-A (anxiety rating scale), YMRS (mania rating scale), GAF (global functioning scale), SDD (disability scale) and Q-LES-Q (quality of life scale) at post-baseline collection times
  • Evaluation of movement disorders: Change from Baseline in SAS (total score), BAS (total score and individual items and AIMS (total score and individual items)
  • Effect of study drug on ECGs, laboratory values, vital signs and physical exam observations
  • Adverse Events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
Official Title  ICMJE A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression
Brief Summary The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Depression, Bipolar
Intervention  ICMJE
  • Drug: Ziprasidone
    Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
    Other Name: Geodon, Zeldox
  • Drug: Placebo
    Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Study Arms  ICMJE
  • Experimental: Ziprasidone
    Active treatment, double-blind, randomized treatment arm
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: Placebo
    Inactive, placebo treatment, double-blind, randomized arm
    Intervention: Drug: Placebo
Publications * Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. 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 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2009)
298
Original Enrollment  ICMJE
 (submitted: June 5, 2007)
282
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion Criteria:

  • Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
  • Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
  • Psychotic symptoms (hallucinations and/or delusions).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483548
Other Study ID Numbers  ICMJE A1281158
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP