Trial record 2 of 2 for:    Pharmacogenomics of Bipolar Disorder

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00312494
First received: April 6, 2006
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects


Condition Intervention Phase
Bipolar Disorder
Drug: Placebo
Drug: Ziprasidone
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 Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 1 and Week 2 in YMRS [ Time Frame: Baseline, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores [ Time Frame: Baseline, Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score [ Time Frame: Baseline, Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement (CGI-I) Scale Scores [ Time Frame: Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Global Assessment of Functioning (GAF) Score [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Anonymized Pharmacogenomic Blood Draw [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 680
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo with mood stabilizer (either lithium or divalproex)
Experimental: Ziprasidone 20-40mg twice a day (BID) Drug: Ziprasidone
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Other Name: Geodon, Zeldox
Experimental: Ziprasidone 60-80mg BID Drug: Ziprasidone
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Other Name: Geodon, Zeldox

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
  • At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
  • Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

Exclusion Criteria:

  • Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
  • Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.
  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: NCT00312494

  Show 67 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: NCT00312494     History of Changes
Other Study ID Numbers: A1281143
Study First Received: April 6, 2006
Results First Received: December 17, 2009
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014