Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00280566
First received: January 19, 2006
Last updated: January 5, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.


Condition Intervention Phase
Bipolar Mania
Bipolar Disorder
Drug: Placebo
Drug: Ziprasidone Oral Capsule
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 Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to Intervention for a Mood Episode During Double Blind Period [ Time Frame: Period 2: 24 weeks or time of early termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Discontinuation for Any Reason During Double Blind Period 2 [ Time Frame: Period 2: 24 weeks or time of early termination ] [ Designated as safety issue: No ]
  • Modified Time to Intervention for a Mood Episode (TIME) [ Time Frame: Period 2: Week 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 1 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 1 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 1 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 1 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 4 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 4 - 24 or time of early termination ] [ Designated as safety issue: No ]
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period [ Time Frame: Period 2: Weeks 4 - 24 or time of early termination ] [ Designated as safety issue: No ]

Enrollment: 584
Study Start Date: December 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone
Active treatment, double-blind, randomized arm
Drug: Ziprasidone Oral Capsule
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
Other Name: Geodon, Zeldox
Placebo Comparator: Placebo
Placebo treatment, double-blind, randomized arm
Drug: Placebo
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.

  Eligibility

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

Inclusion Criteria:

Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

Exclusion Criteria:

Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome

  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: NCT00280566

  Show 108 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: NCT00280566     History of Changes
Other Study ID Numbers: A1281137
Study First Received: January 19, 2006
Results First Received: May 6, 2009
Last Updated: January 5, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
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 October 21, 2014