A Six-Week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00282464

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 I Depression	Drug: Placebo Drug: Geodon (Ziprasidone)	Phase III

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate BaseLine

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, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression

Further study details as provided by Pfizer:

Primary Outcome Measures:

Compare efficacy of ziprasidone to placebo over 6-weeks in outpatients with Bipolar Disorder Type I, depressed who have HAM-D-17 score >or= 20 and a YMRS score <or= 12. Primary efficacy measure will be the change from baseline in the [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
MADRS total score. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the 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-Sziprasidone flexible dosing treatment arm (20-80 mg bid) everity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Efficacy in depressive symptoms using the HAM-D-17 and 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 ]

Enrollment:	392
Study Start Date:	February 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ziprasidone 20 and 60mg: Active Comparator For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).	Drug: Geodon (Ziprasidone) Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
Placebo: Placebo Comparator	Drug: Placebo Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

Arms

Assigned Interventions

Ziprasidone 20 and 60mg: Active Comparator

For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Drug: Geodon (Ziprasidone)

Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Placebo: Placebo Comparator

Drug: Placebo

Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

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: NCT00282464

Show 43 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:	A1281139
Study First Received:	January 24, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00282464
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bipolar I Depression

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood 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 16, 2009