A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141271

Purpose

This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Geodon (Ziprasidone) Drug: Placebo	Phase III

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral Ziprasidone in Outpatients With Bipolar I Depression

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy measure will be the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Compare the efficacy of ziprasidone to placebo over a 6-week course of treatment in outpatients with a diagnosis of Bipolar Disorder Type I, depressed, with or without rapid cycling, who have a HAM-D-17 score > 20 and a YMRS score < 12. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage change in quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) short form [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Occupational/psychosocial impact of symptoms using the Sheehan Disability Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Global functioning using the GAF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evaluate cognition using the BAC-A [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evaluate pharmacogenomic basis for ziprasidone treatment response. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Efficacy in depressive symptoms using the HAM-D-17 and the HAM-D-25 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Improvement in anxiety symptoms using the HAM-A [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Incidence of manic symptoms and/or switch using the YMRS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Global clinical severity of symptoms using the CGI-Severity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Global clinical improvement of symptoms using the CGI-Improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	539
Study Start Date:	July 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
20-40mg BID arm: Active Comparator	Drug: Geodon (Ziprasidone) Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
60-80mg bid arm: Active Comparator	Drug: Geodon (Ziprasidone) Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
Placebo: Placebo Comparator	Drug: Placebo Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial

Eligibility

Ages Eligible for Study:	18 Years and older
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 depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder NOS (298.9).
Subjects with other DSM-IV TR Axis I or Axis II disorder (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: NCT00141271

Show 74 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281136
Study First Received:	August 30, 2005
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00141271
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bipolar I Disorder

Study placed in the following topic categories:

Affective Disorders, Psychotic
Dopamine
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders

Psychotic Disorders
Ziprasidone
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009