Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
A1281158
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder
0
0
Query!
Depression, Bipolar
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Depression
Query!
Mental Health
0
0
0
0
Query!
Other mental health disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Week 6
Query!
Secondary outcome [1]
0
0
Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Week 6
Query!
Secondary outcome [2]
0
0
MADRS Remission: Number of Subjects With Total MADRS Score = 12 at Week 6
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Week 6
Query!
Secondary outcome [3]
0
0
MADRS Response: Number of Subjects With Total MADRS Score Reduction = 50 Percent From Baseline at Week 6
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 6
Query!
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
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, Week 6
Query!
Secondary outcome [5]
0
0
Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Query!
Secondary outcome [6]
0
0
Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Query!
Secondary outcome [7]
0
0
CGI-Improvement Score
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Query!
Secondary outcome [8]
0
0
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline, Week 2, Week 4, Week 6
Query!
Secondary outcome [9]
0
0
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Query!
Secondary outcome [10]
0
0
Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline, Week 6
Query!
Secondary outcome [11]
0
0
Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline, Week 6
Query!
Secondary outcome [12]
0
0
Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline, Week 6
Query!
Secondary outcome [13]
0
0
Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline, Week 6
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
298
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Westmead
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Everton Park
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Spring Hill
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Richmond
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
4053 - Everton Park
Query!
Recruitment postcode(s) [3]
0
0
4000 - Spring Hill
Query!
Recruitment postcode(s) [4]
0
0
3121 - Richmond
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Hampshire
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Wisconsin
Query!
Country [27]
0
0
India
Query!
State/province [27]
0
0
Ahmedabad
Query!
Country [28]
0
0
India
Query!
State/province [28]
0
0
Gujarat
Query!
Country [29]
0
0
India
Query!
State/province [29]
0
0
Maharashtra
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
New Delhi
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00483548
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00483548
Download to PDF