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

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ClinicalTrials.gov Identifier: NCT00312494
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : January 22, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

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

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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


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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00312494


  Show 67 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00312494     History of Changes
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:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Ziprasidone
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Dopamine Antagonists
Dopamine Agents