Clinical trial NCT00141271: A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
timeFrame: Baseline to 6 weeks
measure: Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
timeFrame: Baseline to 6 weeks
measure: Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
timeFrame: Baseline, 6 Weeks LOCF
measure: Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
timeFrame: Baseline to 6 weeks
measure: Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
timeFrame: Baseline to 6 weeks
measure: Change in Hamilton Depression (HAM-D 17) Total Score
timeFrame: Baseline to 6 weeks
measure: Change in Hamilton Anxiety Rating (HAM-A)
timeFrame: Baseline to 6 weeks
measure: Change in Total Score of Young Mania Rating Scale (YMRS)
timeFrame: Baseline to 6 weeks
measure: Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
timeFrame: Baseline to 6 weeks
measure: Change in Global Clinical Improvement of Symptoms (CGI -I)
timeFrame: Baseline to 6 weeks
measure: Change in Total Score in Hamilton Depression (HAM-D 25)
timeFrame: Baseline to 6 Weeks
measure: Response as Measured by CGI-I Score Less Than or Equal to 2
timeFrame: Week 1 through Week 6 (endpoint)
measure: Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
timeFrame: Baseline to Week 6
measure: Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
timeFrame: Baseline to 6 Weeks
measure: Change in Bech Melancholia Score
timeFrame: Baseline to 6 Weeks
measure: Change in Anxiety/Somatizations Factor Total Score
timeFrame: Baseline to 6 Weeks
measure: Change in Retardation Factor Scores
timeFrame: Baseline to 6 Weeks
measure: Change in Sleep Disturbance Factor Score
timeFrame: Baseline to 6 weeks
measure: Change in Verbal Memory Trial Performance Total Score at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
timeFrame: Baseline to Week 6 LOCF
measure: Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
timeFrame: Baseline to Week 6 LOCF
measure: Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Digit Sequencing Task at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Token Motor Task at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Verbal Fluency in Naming Categories at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Verbal Fluency Controlled Word Association at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Symbol Coding at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Tower of London Test at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
timeFrame: Baseline to 6 Weeks LOCF
measure: Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
timeFrame: Baseline to Week 6 LOCF
measure: Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
timeFrame: Baseline to Week 6 LOCF
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Dana Point
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Naperville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Greenwood
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Prarie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Clementon
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Galveston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richardson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Falls Church
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: West Allis
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Keefe RS, Fox KH, Davis VG, Kennel C, Walker TM, Burdick KE, Harvey PD. The Brief Assessment of Cognition In Affective Disorders (BAC-A):performance of patients with bipolar depression and healthy controls. J Affect Disord. 2014 Sep;166:86-92. doi: 10.1016/j.jad.2014.05.002. Epub 2014 May 11.
citation: Gao K, Pappadopulos E, Karayal ON, Kolluri S, Calabrese JR. Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. J Clin Psychopharmacol. 2013 Jun;33(3):425-31. doi: 10.1097/JCP.0b013e3182917f3f.