Clinical trial NCT00483548: Adjunctive Ziprasidone in the Treatment of 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 As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Depression, Bipolar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 298
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: The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion Criteria:

* Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
* Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
* Psychotic symptoms (hallucinations and/or delusions).

Primary outcomes:
measure: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)
timeFrame: Baseline, Week 6
measure: MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6
timeFrame: Week 6
measure: MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6
timeFrame: Week 6
measure: Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
measure: Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
measure: CGI-Improvement Score
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
measure: Change From Baseline in Simpson Angus Scale (SAS) Score
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores
timeFrame: Baseline, Week 2, Week 4, Week 6
Locations:
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sanford
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Greenwood
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Topeka
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Clinton Township
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Saint Charles
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Nashua
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Clementon
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Glen Oaks
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: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Richland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Brown Deer
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Everton Park
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Spring Hill
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Richmond
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Ellisbridge
country: India
facility: Pfizer Investigational Site
state: Ahmedabad
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Aurangabad
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Delhi
country: India
facility: Pfizer Investigational Site
state: New Delhi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.