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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00483548




Registration number
NCT00483548
Ethics application status
Date submitted
5/06/2007
Date registered
7/06/2007
Date last updated
10/03/2021

Titles & IDs
Public title
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
Scientific 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
Secondary ID [1] 0 0
A1281158
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Depression, Bipolar 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ziprasidone
Treatment: Drugs - Placebo

Experimental: Ziprasidone - Active treatment, double-blind, randomized treatment arm

Placebo comparator: Placebo - Inactive, placebo treatment, double-blind, randomized arm


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
MADRS Remission: Number of Subjects With Total MADRS Score = 12 at Week 6
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
MADRS Response: Number of Subjects With Total MADRS Score Reduction = 50 Percent From Baseline at Week 6
Timepoint [3] 0 0
Week 6
Secondary outcome [4] 0 0
Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6
Timepoint [4] 0 0
Baseline, Week 6
Secondary outcome [5] 0 0
Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)
Timepoint [5] 0 0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Secondary outcome [6] 0 0
Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)
Timepoint [6] 0 0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Secondary outcome [7] 0 0
CGI-Improvement Score
Timepoint [7] 0 0
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Secondary outcome [8] 0 0
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score
Timepoint [8] 0 0
Baseline, Week 2, Week 4, Week 6
Secondary outcome [9] 0 0
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
Timepoint [9] 0 0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Secondary outcome [10] 0 0
Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6
Timepoint [10] 0 0
Baseline, Week 6
Secondary outcome [11] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)
Timepoint [11] 0 0
Baseline, Week 6
Secondary outcome [12] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)
Timepoint [12] 0 0
Baseline, Week 6
Secondary outcome [13] 0 0
Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6
Timepoint [13] 0 0
Baseline, Week 6

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
298
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Everton Park
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Spring Hill
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Richmond
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment postcode(s) [3] 0 0
4000 - Spring Hill
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
India
State/province [27] 0 0
Ahmedabad
Country [28] 0 0
India
State/province [28] 0 0
Gujarat
Country [29] 0 0
India
State/province [29] 0 0
Maharashtra
Country [30] 0 0
India
State/province [30] 0 0
New Delhi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00483548