- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141271
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety 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)
536
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
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Pfizer Investigational Site
-
-
California
-
Dana Point, California, United States, 92629
- Pfizer Investigational Site
-
La Mesa, California, United States, 91942
- Pfizer Investigational Site
-
Laguna Hills, California, United States, 92653
- Pfizer Investigational Site
-
Oceanside, California, United States, 92056
- Pfizer Investigational Site
-
Orange, California, United States, 92868
- Pfizer Investigational Site
-
San Diego, California, United States, 92108
- Pfizer Investigational Site
-
San Diego, California, United States, 92120
- Pfizer Investigational Site
-
Santa Ana, California, United States, 92705
- Pfizer Investigational Site
-
Torrance, California, United States, 90505
- Pfizer Investigational Site
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33319
- Pfizer Investigational Site
-
Gainesville, Florida, United States, 32607
- Pfizer Investigational Site
-
Hialeah, Florida, United States, 33016
- Pfizer Investigational Site
-
Jacksonville, Florida, United States, 32216
- Pfizer Investigational Site
-
North Miami, Florida, United States, 33161
- Pfizer Investigational Site
-
Orlando, Florida, United States, 32806
- Pfizer Investigational Site
-
Winter Park, Florida, United States, 32789
- Pfizer Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Pfizer Investigational Site
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Pfizer Investigational Site
-
Naperville, Illinois, United States, 60563
- Pfizer Investigational Site
-
Schaumburg, Illinois, United States, 60194
- Pfizer Investigational Site
-
-
Indiana
-
Greenwood, Indiana, United States, 46143
- Pfizer Investigational Site
-
Lafayette, Indiana, United States, 47905
- Pfizer Investigational Site
-
-
Kansas
-
Prarie Village, Kansas, United States, 66206
- Pfizer Investigational Site
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70114
- Pfizer Investigational Site
-
Shreveport, Louisiana, United States, 71101
- Pfizer Investigational Site
-
Shreveport, Louisiana, United States, 71105
- Pfizer Investigational Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Pfizer Investigational Site
-
Worcester, Massachusetts, United States, 01605
- Pfizer Investigational Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- Pfizer Investigational Site
-
-
Mississippi
-
Flowood, Mississippi, United States, 39232
- Pfizer Investigational Site
-
-
Missouri
-
Saint Louis, Missouri, United States, 63128
- Pfizer Investigational Site
-
Saint Louis, Missouri, United States, 63144
- Pfizer Investigational Site
-
-
Nebraska
-
Omaha, Nebraska, United States, 68131
- Pfizer Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- Pfizer Investigational Site
-
-
New Jersey
-
Clementon, New Jersey, United States, 08021
- Pfizer Investigational Site
-
Toms River, New Jersey, United States, 08755
- Pfizer Investigational Site
-
-
New York
-
New York, New York, United States, 10021
- Pfizer Investigational Site
-
Staten Island, New York, United States, 10305
- Pfizer Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267-0001
- Pfizer Investigational Site
-
Cleveland, Ohio, United States, 44106
- Pfizer Investigational Site
-
Cleveland, Ohio, United States, 44113
- Pfizer Investigational Site
-
Mayfield, Ohio, United States, 44143
- Pfizer Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73118
- Pfizer Investigational Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19131
- Pfizer Investigational Site
-
Philadelphia, Pennsylvania, United States, 19149
- Pfizer Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15213
- Pfizer Investigational Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Pfizer Investigational Site
-
Columbia, South Carolina, United States, 29201
- Pfizer Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- Pfizer Investigational Site
-
Nashville, Tennessee, United States, 37203-1515
- Pfizer Investigational Site
-
-
Texas
-
Bellaire, Texas, United States, 77401
- Pfizer Investigational Site
-
Dallas, Texas, United States, 75216
- Pfizer Investigational Site
-
Dallas, Texas, United States, 75234
- Pfizer Investigational Site
-
DeSoto, Texas, United States, 75115
- Pfizer Investigational Site
-
Galveston, Texas, United States, 77555-0188
- Pfizer Investigational Site
-
Houston, Texas, United States, 77555
- Pfizer Investigational Site
-
Irving, Texas, United States, 75062
- Pfizer Investigational Site
-
Plano, Texas, United States, 75093
- Pfizer Investigational Site
-
Richardson, Texas, United States, 75080
- Pfizer Investigational Site
-
San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, United States, 78284-7792
- Pfizer Investigational Site
-
Wichita Falls, Texas, United States, 76309
- Pfizer Investigational Site
-
-
Virginia
-
Arlington, Virginia, United States, 22201
- Pfizer Investigational Site
-
Falls Church, Virginia, United States, 22041
- Pfizer Investigational Site
-
Richmond, Virginia, United States, 23229
- Pfizer Investigational Site
-
Richmond, Virginia, United States, 23230
- Pfizer Investigational Site
-
Virginia Beach, Virginia, United States, 23452
- Pfizer Investigational Site
-
-
Washington
-
Kirkland, Washington, United States, 98033
- Pfizer Investigational Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Pfizer Investigational Site
-
Milwaukee, Wisconsin, United States, 53227
- Pfizer Investigational Site
-
West Allis, Wisconsin, United States, 53227
- Pfizer Investigational Site
-
-
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 Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (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 not otherwise specified (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 |
---|---|
Placebo Comparator: Placebo
|
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
|
Active Comparator: 20-40mg BID arm
|
Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
|
Active Comparator: 60-80mg bid arm
|
Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal).
Total possible score is 0 - 60.
|
Baseline to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Time Frame: Baseline to 6 weeks
|
Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no.
Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal).
Total possible score is 0 - 60
|
Baseline to 6 weeks
|
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 6 weeks
|
Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no.
Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe.
Total possible score 0 - 52.
|
Baseline to 6 weeks
|
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
Time Frame: Baseline, 6 Weeks LOCF
|
Change is observed value at endpoint minus baseline value.
Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality
|
Baseline, 6 Weeks LOCF
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Time Frame: Baseline to 6 weeks
|
Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no.
Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)
|
Baseline to 6 weeks
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Time Frame: Baseline to 6 weeks
|
Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no.
Endpoint is LOCF endpoint among Week 1 through Week 6.
Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe.
Total possible score 0 - 52.
|
Baseline to 6 weeks
|
Change in Hamilton Depression (HAM-D 17) Total Score
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.
Total possible score 0 - 52.
|
Baseline to 6 weeks
|
Change in Hamilton Anxiety Rating (HAM-A)
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe).
Total possible score is 0 - 56.
|
Baseline to 6 weeks
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 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.
|
Baseline to 6 weeks
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness.
Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
|
Baseline to 6 weeks
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Overall is average response of Weeks 1 - 6. 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
|
Baseline to 6 weeks
|
Change in Total Score in Hamilton Depression (HAM-D 25)
Time Frame: Baseline to 6 Weeks
|
Change: observed value at each visit minus baseline value.
Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced.
25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.
|
Baseline to 6 Weeks
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Time Frame: Week 1 through Week 6 (endpoint)
|
Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition.
Scale range: 0=not assessed, 1=very much improved, 7=very much worse
|
Week 1 through Week 6 (endpoint)
|
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
Time Frame: Baseline to Week 6
|
Observed value each visit minus baseline value.
Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption).
Total possible is 30.
|
Baseline to Week 6
|
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
Time Frame: Baseline to 6 Weeks
|
Change is observed value at each visit minus baseline value.
LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank).
Total possible score 15 - 80
|
Baseline to 6 Weeks
|
Change in Bech Melancholia Score
Time Frame: Baseline to 6 Weeks
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D).
Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.
|
Baseline to 6 Weeks
|
Change in Anxiety/Somatizations Factor Total Score
Time Frame: Baseline to 6 Weeks
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D).
Scale range is 0 to 4, higher scores reflecting greater severity.
Total possible 0 - 24.
|
Baseline to 6 Weeks
|
Change in Retardation Factor Scores
Time Frame: Baseline to 6 Weeks
|
Change is observed value at each visit minus baseline value.
This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D).
Scale range is 0 to 4 with higher scores reflecting greater severity.
Total possible is 0 - 16.
|
Baseline to 6 Weeks
|
Change in Sleep Disturbance Factor Score
Time Frame: Baseline to 6 weeks
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D).
Scale range 0 to 4 with higher scores reflecting greater severity.
Total possible is 0 - 12.
|
Baseline to 6 weeks
|
Change in Verbal Memory Trial Performance Total Score at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times.
Range 0-75 words, higher number reflects better recall.
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
Time Frame: Baseline to Week 6 LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall
|
Baseline to Week 6 LOCF
|
Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
Time Frame: Baseline to Week 6 LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall
|
Baseline to Week 6 LOCF
|
Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall
|
Baseline to 6 Weeks LOCF
|
Change in Digit Sequencing Task at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest.
Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.
|
Baseline to 6 Weeks LOCF
|
Change in Token Motor Task at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds.
The higher number of tokens placed = patient is better at motor tasks
|
Baseline to 6 Weeks LOCF
|
Change in Verbal Fluency in Naming Categories at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category.
The more words named=better cognition.
|
Baseline to 6 Weeks LOCF
|
Change in Verbal Fluency Controlled Word Association at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition.
Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words
|
Baseline to 6 Weeks LOCF
|
Change in Symbol Coding at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition.
For 90 seconds, Patient writes numerals 1-9 as matched to symbols.
Range 0 to 110 with higher totals = better cognition.
|
Baseline to 6 Weeks LOCF
|
Change in Tower of London Test at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment.
Range: 0-22; more correct = better cognition.
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured.
Range 0-75 with higher numbers showing better cognition.
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
Time Frame: Baseline to 6 Weeks LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition).
Higher number = better cognition
|
Baseline to 6 Weeks LOCF
|
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
Time Frame: Baseline to Week 6 LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition
|
Baseline to Week 6 LOCF
|
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
Time Frame: Baseline to Week 6 LOCF
|
Change is observed value at each visit minus baseline value.
Endpoint is LOCF endpoint among Week 1 through Week 6.
This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition).
Higher number of words = greater cognition
|
Baseline to Week 6 LOCF
|
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.
General Publications
- Keefe RS, Fox KH, Davis VG, Kennel C, Walker TM, Burdick KE, Harvey PD. The Brief Assessment of Cognition In Affective Disorders (BAC-A):performance of patients with bipolar depression and healthy controls. J Affect Disord. 2014 Sep;166:86-92. doi: 10.1016/j.jad.2014.05.002. Epub 2014 May 11.
- Gao K, Pappadopulos E, Karayal ON, Kolluri S, Calabrese JR. Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. J Clin Psychopharmacol. 2013 Jun;33(3):425-31. doi: 10.1097/JCP.0b013e3182917f3f.
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
July 1, 2005
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Actual)
March 25, 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
- Mental Disorders
- Bipolar and Related Disorders
- 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
- A1281136
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Bipolar Disorder
-
ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
-
Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
-
Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
-
Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoNot yet recruitingBipolar Disorder | Bipolar Depression | Treatment- Resistant Bipolar Disorder | Type 2 Bipolar DisorderCanada
Clinical Trials on Geodon (Ziprasidone)
-
Donald C. Goff, MDPfizerCompletedSchizophreniaUnited States
-
Yale UniversityCompleted
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedBipolar DisorderUnited States
-
Dr. Reddy's Laboratories LimitedCompletedHealthyUnited States
-
Stanford UniversityPfizerCompleted
-
University Hospitals Cleveland Medical CenterPfizerCompletedBipolar Disorder | Medication AdherenceUnited States
-
Massachusetts General HospitalPfizerCompletedBipolar Disorder | ManiaUnited States
-
Tufts Medical CenterPfizerCompletedDepression | Bipolar Disorder | Bipolar DepressionUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedSchizophrenia | Schizoaffective DisorderUnited States, Germany, Spain, Greece, Brazil, Turkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedSchizophrenia | Bipolar Disorder