3-Week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00312494

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 III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

At screening and at baseline, subjects must have a Young Mania Rating Scale score of 18 or higher. The primary efficacy measure will be the Young Mania Rating Scale (YMRS). [ Time Frame: Baseline, week 1, week 2, week 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the pharmacogenomic basis for ziprasidone treatment responsivity (anonymized pharmacogenomic blood draw) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
To evaluate improvement in overall psychopathology using the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, week 3 ] [ Designated as safety issue: No ]
To evaluate improvement in global clinical severity and improvement of symptoms using the Clinical Global Impression Scale (CGI-Severity) and (CGI-Improvement) [ Time Frame: Baseline, week 1, week 2, week 3 ] [ Designated as safety issue: No ]
To evaluate global functioning using the Global Assessment of Functioning (GAF) and Range of Impaired Functioning Tool (LIFE-RIFT) [ Time Frame: Baseline, week 3 ] [ Designated as safety issue: No ]
To evaluate improvement in depressive symptoms using the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, week 1, week 2, week 3 ] [ 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: Placebo Comparator	Drug: Placebo Placebo with mood stabilizer (either lithium or divalproex)
Ziprasidone 20-40mg BID: Experimental	Drug: Ziprasidone Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Ziprasidone 60-80mg BID: Experimental	Drug: Ziprasidone Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312494

Show 69 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281143
Study First Received:	April 6, 2006
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00312494 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Lithium Carbonate
Central Nervous System Depressants
Antipsychotic Agents
Antimanic Agents
Serotonin

Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Psychotic Disorders
Ziprasidone
Lithium

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antimanic Agents
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Affective Disorders, Psychotic
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Ziprasidone
Central Nervous System Agents
Lithium

ClinicalTrials.gov processed this record on May 07, 2009