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Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00483548
First received: June 5, 2007
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • CGI-Improvement Score [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483548

  Show 70 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014