Clinical trial NCT00282464: A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar I Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-26
Enrollment: 392
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 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.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 6
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 Week 3, Week 6
measure: Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
timeFrame: Week 1 to Week 6
measure: Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
timeFrame: Week 3, Week 6
measure: Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
timeFrame: Baseline to Weeks 3, 6
measure: Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
timeFrame: Baseline to Weeks 3, 6
measure: Change in Bech Melancholia Score
timeFrame: Baseline to Weeks 3, 6
measure: Change in Anxiety/Somatizations Factor Total Score
timeFrame: Baseline to Weeks 3, 6
measure: Change in Retardation Factor Scores
timeFrame: Baseline to Weeks 3, 6
measure: Change in Sleep Disturbance Factor Score
timeFrame: Baseline to Weeks 3, 6
measure: Change in Hamilton Anxiety Rating (HAM-A)
timeFrame: Baseline to Weeks 3, 6
measure: Change in Total Score of Young Mania Rating Scale (YMRS)
timeFrame: Baseline to week 6
measure: Change in Global Clinical Severity of Symptoms (CGI-S)
timeFrame: Baseline to week 6
measure: Change in Global Clinical Improvement of Symptoms (CGI -I)
timeFrame: Baseline to Week 6
measure: Change in Global Assessment of Functioning (GAF)
timeFrame: Baseline to week 6 (Endpoint)
measure: Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
timeFrame: Baseline to week 6 (endpoint)
measure: Change in Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to week 6 (endpoint)
measure: Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
timeFrame: Baseline to week 6 (endpoint)
measure: Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
timeFrame: Baseline to week 6 (endpoint)
measure: Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
timeFrame: Baseline to week 6 (endpoint)
measure: Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
timeFrame: Baseline to Week 6 (endpoint)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Escondido
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
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: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Darien
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Eagle
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Granite City
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Glen Burnie
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Towson
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Olean
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Scranton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.