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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00483548
Other study ID # A1281158
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2007
Est. completion date December 2008

Study information

Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 298
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Drug:
Ziprasidone
Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
Placebo
Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Locations

Country Name City State
Australia Pfizer Investigational Site Everton Park Queensland
Australia Pfizer Investigational Site Richmond Victoria
Australia Pfizer Investigational Site Spring Hill Queensland
Australia Pfizer Investigational Site Westmead New South Wales
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Aurangabad Maharashtra
India Pfizer Investigational Site Delhi New Delhi
India Pfizer Investigational Site Ellisbridge Ahmedabad
India Pfizer Investigational Site Pune Maharashtra
India Pfizer Investigational Site Pune Maharashtra
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Brown Deer Wisconsin
United States Pfizer Investigational Site Chandler Arizona
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Cherry Hill New Jersey
United States Pfizer Investigational Site Chicago Illinois
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 Clinton Township Michigan
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Costa Mesa California
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Glen Oaks New York
United States Pfizer Investigational Site Greenwood Indiana
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kirkland Washington
United States Pfizer Investigational Site Lake Charles Louisiana
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Litchfield Park Arizona
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Nashua New Hampshire
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Oceanside California
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Olean New York
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Richland Washington
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rockville Maryland
United States Pfizer Investigational Site Saint Charles Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sanford Florida
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Skokie Illinois
United States Pfizer Investigational Site Springdale Arkansas
United States Pfizer Investigational Site Staten Island New York
United States Pfizer Investigational Site Topeka Kansas
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Watertown Massachusetts
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wichita Kansas

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Australia,  India, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in Simpson Angus Scale (SAS) Score SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values. Baseline, Week 2, Week 4, Week 6
Other Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS) BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values. Baseline, Week 2, Week 4, Week 6
Other Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values. Baseline, Week 2, Week 4, Week 6
Primary Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score 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); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. Baseline, Week 6
Secondary Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S) 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. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. Baseline, Week 6
Secondary MADRS Remission: Number of Subjects With Total MADRS Score = 12 at Week 6 Number of subjects with MADRS total score = 12 (indicates remission). 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); total score 0 to 44 (higher score indicates greater severity of symptoms). Week 6
Secondary MADRS Response: Number of Subjects With Total MADRS Score Reduction = 50 Percent From Baseline at Week 6 Number of subjects with reduction of =50 percent (%) in MADRS total score (indicates response). 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); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value. Week 6
Secondary Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6 Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). 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. Baseline, Week 6
Secondary Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6) 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); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Secondary Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6) 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. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Secondary CGI-Improvement Score 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 6 is the primary timepoint. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Secondary Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint. Baseline, Week 2, Week 4, Week 6
Secondary Change From Baseline in Young Mania Rating Scale (YMRS) Total Score YMRS is clinician rated 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. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint. Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Secondary Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6 GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values. Baseline, Week 6
Secondary Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3) SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. Baseline, Week 6
Secondary Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5) SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. Baseline, Week 6
Secondary Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6 Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values. Baseline, Week 6
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