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Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: June 5, 2007
Last updated: February 4, 2010
Last verified: February 2010
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.

Condition Intervention Phase
Bipolar Disorder
Depression, Bipolar
Drug: Ziprasidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 298
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone
Active treatment, double-blind, randomized treatment arm
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
Placebo Comparator: Placebo
Inactive, placebo treatment, double-blind, randomized arm
Drug: Placebo
Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00483548

  Show 70 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00483548     History of Changes
Other Study ID Numbers: A1281158
Study First Received: June 5, 2007
Results First Received: December 22, 2009
Last Updated: February 4, 2010

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017