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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Bipolar Disorder Depression

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 6 Weeks LOCF ] [ Designated as safety issue: No ]
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Hamilton Depression (HAM-D 17) Total Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Total Score in Hamilton Depression (HAM-D 25) [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
Response as Measured by CGI-I Score Less Than or Equal to 2 [ Time Frame: Week 1 through Week 6 (endpoint) ] [ Designated as safety issue: No ]
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
Change in Bech Melancholia Score [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
Change in Retardation Factor Scores [ Time Frame: Baseline to 6 Weeks ] [ Designated as safety issue: No ]
Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in Verbal Memory Trial Performance Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Digit Sequencing Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Token Motor Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Verbal Fluency in Naming Categories at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Verbal Fluency Controlled Word Association at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Symbol Coding at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Tower of London Test at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to Week 6 LOCF ] [ Designated as safety issue: No ]

Enrollment:	536
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
Active Comparator: 20-40mg BID arm	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
Active Comparator: 60-80mg bid arm	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 Comparator: Placebo	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 Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (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 not otherwise specified (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 73 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:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00141271 History of Changes
Other Study ID Numbers:	A1281136
Study First Received:	August 30, 2005
Results First Received:	February 24, 2009
Last Updated:	April 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bipolar I Disorder

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013