- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282464
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed.
Subjects are required to undergo a washout period of at least 7 days of any prior med.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
392
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Dothan, Alabama, United States, 36303
- Pfizer Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 77205
- Pfizer Investigational Site
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California
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Anaheim, California, United States, 92804
- Pfizer Investigational Site
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Cerritos, California, United States, 90703
- Pfizer Investigational Site
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Chula Vista, California, United States, 91910
- Pfizer Investigational Site
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Escondido, California, United States, 92025
- Pfizer Investigational Site
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Los Angeles, California, United States, 90027-5302
- Pfizer Investigational Site
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Riverside, California, United States, 92506
- Pfizer Investigational Site
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San Diego, California, United States, 92126
- Pfizer Investigational Site
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Santa Ana, California, United States, 92705
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, United States, 80220
- Pfizer Investigational Site
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Connecticut
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Darien, Connecticut, United States, 06820
- Pfizer Investigational Site
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Florida
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Boca Raton, Florida, United States, 33432
- Pfizer Investigational Site
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Bradenton, Florida, United States, 34208
- Pfizer Investigational Site
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Jacksonville, Florida, United States, 32256-2006
- Pfizer Investigational Site
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Melbourne, Florida, United States, 32901
- Pfizer Investigational Site
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Orange City, Florida, United States, 32763
- Pfizer Investigational Site
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Tampa, Florida, United States, 33613
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Pfizer Investigational Site
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Marietta, Georgia, United States, 30060
- Pfizer Investigational Site
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Idaho
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Eagle, Idaho, United States, 83616
- Pfizer Investigational Site
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Illinois
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Granite City, Illinois, United States, 62040-4749
- Pfizer Investigational Site
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Indiana
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Terre Haute, Indiana, United States, 47802
- Pfizer Investigational Site
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Maryland
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Glen Burnie, Maryland, United States, 21061
- Pfizer Investigational Site
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Towson, Maryland, United States, 21204
- Pfizer Investigational Site
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Minnesota
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Rochester, Minnesota, United States, 55905
- Pfizer Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63118
- Pfizer Investigational Site
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New Jersey
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Princeton, New Jersey, United States, 08540
- Pfizer Investigational Site
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New York
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Brooklyn, New York, United States, 11235
- Pfizer Investigational Site
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Brooklyn, New York, United States, 11223
- Pfizer Investigational Site
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New York, New York, United States, 10003
- Pfizer Investigational Site
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Olean, New York, United States, 14760
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27704
- Pfizer Investigational Site
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Raleigh, North Carolina, United States, 27609
- Pfizer Investigational Site
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Ohio
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Toledo, Ohio, United States, 43623
- Pfizer Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74135
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19149
- Pfizer Investigational Site
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Scranton, Pennsylvania, United States, 18503
- Pfizer Investigational Site
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75231
- Pfizer Investigational Site
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Houston, Texas, United States, 77007
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Virginia
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Charlottesville, Virginia, United States, 22903-4895
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder NOS (298.9).
- Subjects with other DSM-IV TR Axis I or Axis II disorder (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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Subjects will start on placebo and remain on placebo for six weeks.
All cards for the Placebo arm will be 0 mg bid.
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Active Comparator: Ziprasidone 20 and 60mg
For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6.
Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
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Ziprasidone flexible dosing treatment arm (20-80 mg bid).
For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6.
Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline to Week 6
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Change is observed value at each visit minus baseline value.
MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item.
Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.
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Baseline to Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Time Frame: Baseline to Week 6
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Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no.
MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item.
Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)
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Baseline to Week 6
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Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Time Frame: Baseline to Week 3, Week 6
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Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no.
Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms.
Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe.
Total possible score is 0 - 52.
Endpoint is LOCF.
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Baseline to Week 3, Week 6
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Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Time Frame: Week 1 to Week 6
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Remission response is yes if MADRS total score less than or equal to 12; if not, response is no.
MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.
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Week 1 to Week 6
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Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Time Frame: Week 3, Week 6
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Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no.
Total score is first 17 items of HAM-D 25, measures range of depressive symptoms.
Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe.
Total possible score is 0 - 52.
Endpoint is LOCF.
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Week 3, Week 6
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Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing.
Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.
Total possible score is 0 - 52.Endpoint is LOCF
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Baseline to Weeks 3, 6
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Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing.
Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.
Total possible score is 0 - 72.
Endpoint is LOCF.
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Baseline to Weeks 3, 6
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Change in Bech Melancholia Score
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D.
Scale range 0 to 4; higher scores, greater severity.
Total possible score is 0 - 24.
Endpoint is LOCF.
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Baseline to Weeks 3, 6
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Change in Anxiety/Somatizations Factor Total Score
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D.
Scale range 0 to 4 with higher scores reflecting greater severity.
Total possible score is 0 - 24.
Endpoint is LOCF.
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Baseline to Weeks 3, 6
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Change in Retardation Factor Scores
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D.
Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.
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Baseline to Weeks 3, 6
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Change in Sleep Disturbance Factor Score
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D).
Scale range 0 to 4 with higher scores reflecting greater severity.
Total possible score is 0 - 12.
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Baseline to Weeks 3, 6
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Change in Hamilton Anxiety Rating (HAM-A)
Time Frame: Baseline to Weeks 3, 6
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Change is observed value at each visit minus baseline value.
HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe).
Total possible score is 0 - 56.
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Baseline to Weeks 3, 6
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Change in Total Score of Young Mania Rating Scale (YMRS)
Time Frame: Baseline to week 6
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Change is observed value at each visit minus baseline value.
YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items.
0=normal; 4 or 8=most abnormal.
Total possible score is 0 - 60. Overall is average response Week 1 - 6.
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Baseline to week 6
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Change in Global Clinical Severity of Symptoms (CGI-S)
Time Frame: Baseline to week 6
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Change is observed value at each visit minus baseline value.
CGI-S is an instrument to measure severity of mental illness.
Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
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Baseline to week 6
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Change in Global Clinical Improvement of Symptoms (CGI -I)
Time Frame: Baseline to Week 6
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Change is observed value at each visit minus baseline value.
CGI-I is an instrument for Global assessment of improvement in patient's condition.
Scale range:0=not assessed, 1=very much improved, 7=very much worse
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Baseline to Week 6
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Change in Global Assessment of Functioning (GAF)
Time Frame: Baseline to week 6 (Endpoint)
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Change is observed value at each visit minus baseline value.
GAF is an instrument used to assess global psychological, social, & occupational functioning.
Scale range: 100 = normal and 0 = greatest abnormality.
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Baseline to week 6 (Endpoint)
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Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
Time Frame: Baseline to week 6 (endpoint)
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Change is observed value at each visit minus baseline value.
Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life.
Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank.
Total possible score 15 - 80.
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Baseline to week 6 (endpoint)
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Change in Sheehan Disability Scale (SDS) Total Score
Time Frame: Baseline to week 6 (endpoint)
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Change is observed value at each visit minus baseline value.
SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities.
Scale range: 0-10 with 0=no disruption,10=extreme disruption.
Total possible score is 0 - 30.
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Baseline to week 6 (endpoint)
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Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
Time Frame: Baseline to week 6 (endpoint)
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Change is observed value at each visit minus baseline value.
BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning.
Scale range:0 to 4, higher numbers, greater impairment.
Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)
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Baseline to week 6 (endpoint)
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Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
Time Frame: Baseline to week 6 (endpoint)
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Change is observed value at each visit minus baseline value.
Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning.
Scale: 0 to 4, higher numbers = greater impairment.
Total possible score is 0 - 80. Endpoint is LOCF.
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Baseline to week 6 (endpoint)
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Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
Time Frame: Baseline to week 6 (endpoint)
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Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.
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Baseline to week 6 (endpoint)
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Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
Time Frame: Baseline to Week 6 (endpoint)
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Change is observed value at each visit minus baseline value.
Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning.
Scale 0 to 4, higher numbers reflecting greater impairment.
Total possible score is 0 - 80. Endpoint is last observation carried forward.
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Baseline to Week 6 (endpoint)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
January 24, 2006
First Submitted That Met QC Criteria
January 24, 2006
First Posted (Estimate)
January 26, 2006
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Bipolar and Related Disorders
- Depression
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Ziprasidone
Other Study ID Numbers
- A1281139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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