COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312494
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : January 22, 2010
Last Update Posted : February 18, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Placebo Drug: Ziprasidone Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, Week 3 ]

Secondary Outcome Measures :
  1. Change From Baseline to Week 1 and Week 2 in YMRS [ Time Frame: Baseline, Week 1, Week 2 ]
  2. Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores [ Time Frame: Baseline, Week 1, Week 2, Week 3 ]
  3. Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score [ Time Frame: Baseline, Week 1, Week 2, Week 3 ]
  4. Clinical Global Impression - Improvement (CGI-I) Scale Scores [ Time Frame: Week 1, Week 2, Week 3 ]
  5. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Baseline, Week 3 ]
  6. Change From Baseline in Global Assessment of Functioning (GAF) Score [ Time Frame: Baseline, Week 3 ]
  7. Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score [ Time Frame: Baseline, Week 3 ]
  8. Anonymized Pharmacogenomic Blood Draw [ Time Frame: Baseline ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312494

Show Show 67 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00312494    
Other Study ID Numbers: A1281143
First Posted: April 10, 2006    Key Record Dates
Results First Posted: January 22, 2010
Last Update Posted: February 18, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental 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