3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312494
• Other study ID #: A1281143
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Placebo
Placebo with mood stabilizer (either lithium or divalproex)
• Ziprasidone
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
• Ziprasidone
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Amityville	New York
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Cedarhurst	New York
United States	Pfizer Investigational Site	Cerritos	California
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Des Plaines	Illinois
United States	Pfizer Investigational Site	Dothan	Alabama
United States	Pfizer Investigational Site	Elmsford	New York
United States	Pfizer Investigational Site	Escondido	California
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Glen Burnie	Maryland
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Greenwood	Indiana
United States	Pfizer Investigational Site	Hartford	Connecticut
United States	Pfizer Investigational Site	Hoffman Estates	Illinois
United States	Pfizer Investigational Site	Hoffman Estates	Illinois
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lauderhill	Florida
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	National City	California
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Prairie Village	Kansas
United States	Pfizer Investigational Site	Princeton	New Jersey
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Saint Charles	Missouri
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Schaumburg	Illinois
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)	YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).	Baseline, Week 3
Secondary	Change From Baseline to Week 1 and Week 2 in YMRS	YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).	Baseline, Week 1, Week 2
Secondary	Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores	MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).	Baseline, Week 1, Week 2, Week 3
Secondary	Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score	CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).	Baseline, Week 1, Week 2, Week 3
Secondary	Clinical Global Impression - Improvement (CGI-I) Scale Scores	CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.	Week 1, Week 2, Week 3
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score	PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).	Baseline, Week 3
Secondary	Change From Baseline in Global Assessment of Functioning (GAF) Score	GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).	Baseline, Week 3
Secondary	Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score	LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores = 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).	Baseline, Week 3
Secondary	Anonymized Pharmacogenomic Blood Draw	Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.	Baseline

External Links

•   To obtain contact information for a study center near you, click here.