Clinical trial NCT00312494: 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Official title: A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-10
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects


Eligibility criteria: Inclusion Criteria:

* Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
* At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
* Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

Exclusion Criteria:

* Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (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 (NOS) (298.9).
* Subjects with other DSM-IV-TR Axis I or Axis II disorders (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 From Baseline to Week 3 in Young Mania Rating Scale (YMRS)
timeFrame: Baseline, Week 3
Secondary outcomes:
measure: Change From Baseline to Week 1 and Week 2 in YMRS
timeFrame: Baseline, Week 1, Week 2
measure: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Clinical Global Impression - Improvement (CGI-I) Scale Scores
timeFrame: Week 1, Week 2, Week 3
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Baseline, Week 3
measure: Change From Baseline in Global Assessment of Functioning (GAF) Score
timeFrame: Baseline, Week 3
measure: Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score
timeFrame: Baseline, Week 3
measure: Anonymized Pharmacogenomic Blood Draw
timeFrame: Baseline
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Escondido
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
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: San Diego
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: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Des Plaines
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Hoffman Estates
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: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Glen Burnie
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
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: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
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: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Amityville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cedarhurst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Elmsford
country: United States
facility: Pfizer Investigational Site
state: New York
city: Raleigh
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: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
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: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
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: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.
citation: Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.