Bipolar DisorderPhase 3NCT00141271
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
A Phase 3 study testing Geodon (Ziprasidone) in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Geodon (Ziprasidone)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 72 sitesUnited States
- Study dates
- Jul 2005to Feb 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Pfizer Investigational Site
Arlington, Virginia, 22201
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Bellaire, Texas, 77401
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0001
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cleveland, Ohio, 44113
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Dallas, Texas, 75216
Pfizer Investigational Site
Dallas, Texas, 75234
Pfizer Investigational Site
Dana Point, California, 92629
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Falls Church, Virginia, 22041
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Fort Lauderdale, Florida, 33319
Pfizer Investigational Site
Gainesville, Florida, 32607
Pfizer Investigational Site
Galveston, Texas, 77555-0188
Pfizer Investigational Site
Greenwood, Indiana, 46143
Pfizer Investigational Site
Hialeah, Florida, 33016
Pfizer Investigational Site
Houston, Texas, 77555
Pfizer Investigational Site
Irving, Texas, 75062
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Lafayette, Indiana, 47905
Pfizer Investigational Site
Laguna Hills, California, 92653
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Mayfield, Ohio, 44143
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Milwaukee, Wisconsin, 53227
Pfizer Investigational Site
Minneapolis, Minnesota, 55454
Pfizer Investigational Site
Naperville, Illinois, 60563
Pfizer Investigational Site
Nashville, Tennessee, 37203-1515
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73118
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19131
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19149
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Prarie Village, Kansas, 66206
Pfizer Investigational Site
Richardson, Texas, 75080
Pfizer Investigational Site
Richmond, Virginia, 23229
Pfizer Investigational Site
Richmond, Virginia, 23230
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78284-7792
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Schaumburg, Illinois, 60194
Pfizer Investigational Site
Shreveport, Louisiana, 71101
Pfizer Investigational Site
Shreveport, Louisiana, 71105
Pfizer Investigational Site
St Louis, Missouri, 63128
Pfizer Investigational Site
St Louis, Missouri, 63144
Pfizer Investigational Site
Staten Island, New York, 10305
Pfizer Investigational Site
Toms River, New Jersey, 08755
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Virginia Beach, Virginia, 23452
Pfizer Investigational Site
West Allis, Wisconsin, 53227
Pfizer Investigational Site
Wichita Falls, Texas, 76309
Pfizer Investigational Site
Winter Park, Florida, 32789
Pfizer Investigational Site
Worcester, Massachusetts, 01605
About this study
Official title: 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.
- Conditions
- Bipolar Disorder
- Being tested
- Geodon (Ziprasidone), Placebo
- Keywords
- Bipolar I Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geodon (Ziprasidone)Drug
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
Geodon (Ziprasidone)Drug
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
PlaceboDrug
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
| Study group | Role | What they receive |
|---|---|---|
| 20-40mg BID arm | Active comparator | Not described Receives: Drug: Geodon (Ziprasidone) |
| 60-80mg bid arm | Active comparator | Not described Receives: Drug: Geodon (Ziprasidone) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
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.
Measured: Baseline to 6 weeks
Secondary outcomes (37)
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
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
Measured: 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
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.
Measured: Baseline to 6 weeks
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (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
Measured: Baseline, 6 Weeks LOCF
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
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)
Measured: Baseline to 6 weeks
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
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.
Measured: Baseline to 6 weeks
Change in Hamilton Depression (HAM-D 17) Total Score
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.
Measured: Baseline to 6 weeks
Change in Hamilton Anxiety Rating (HAM-A)
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.
Measured: Baseline to 6 weeks
Change in Total Score of Young Mania Rating Scale (YMRS)
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.
Measured: Baseline to 6 weeks
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
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
Measured: Baseline to 6 weeks
Change in Global Clinical Improvement of Symptoms (CGI -I)
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
Measured: Baseline to 6 weeks
Change in Total Score in Hamilton Depression (HAM-D 25)
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.
Measured: Baseline to 6 Weeks
Response as Measured by CGI-I Score Less Than or Equal to 2
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
Measured: Week 1 through Week 6 (endpoint)
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
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.
Measured: Baseline to Week 6
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
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
Measured: Baseline to 6 Weeks
Change in Bech Melancholia Score
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.
Measured: Baseline to 6 Weeks
Change in Anxiety/Somatizations Factor Total Score
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.
Measured: Baseline to 6 Weeks
Change in Retardation Factor Scores
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.
Measured: Baseline to 6 Weeks
Change in Sleep Disturbance Factor Score
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.
Measured: Baseline to 6 weeks
Change in Verbal Memory Trial Performance Total Score at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
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
Measured: Baseline to Week 6 LOCF
Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
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
Measured: Baseline to Week 6 LOCF
Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Digit Sequencing Task at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Token Motor Task at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Verbal Fluency in Naming Categories at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Verbal Fluency Controlled Word Association at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Symbol Coding at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Tower of London Test at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
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.
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
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
Measured: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
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
Measured: Baseline to Week 6 LOCF
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
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
Measured: Baseline to Week 6 LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141271
- Sponsor's protocol ID
- A1281136
- Status last verified
- Mar 2021
- First submitted
- 30 Aug 2005
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 25012414Gao 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.
PubMed 23609405
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00141271
- Acronym / sponsor ID
- A1281136
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 24 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20-40mg BID arm | Active comparator | Drug: Geodon (Ziprasidone) |
| 60-80mg bid arm | Active comparator | Drug: Geodon (Ziprasidone) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geodon (Ziprasidone)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 | Drug | 20-40mg BID arm |
| Geodon (Ziprasidone)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 | Drug | 60-80mg bid arm |
| PlaceboSubjects will start on placebo and remain on placebo for the remainder of the 6 week trial | Drug | Placebo |
Primary outcome
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.
37 secondary outcomes
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
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
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
Time frame: 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
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Time frame: Baseline to 6 weeks
Change in Hamilton Depression (HAM-D 17) Total Score
Time frame: Baseline to 6 weeks
Change in Hamilton Anxiety Rating (HAM-A)
Time frame: Baseline to 6 weeks
Change in Total Score of Young Mania Rating Scale (YMRS)
Time frame: Baseline to 6 weeks
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Time frame: Baseline to 6 weeks
Change in Global Clinical Improvement of Symptoms (CGI -I)
Time frame: Baseline to 6 weeks
Change in Total Score in Hamilton Depression (HAM-D 25)
Time frame: 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)
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
Time frame: 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 in Bech Melancholia Score
Time frame: Baseline to 6 Weeks
Change in Anxiety/Somatizations Factor Total Score
Time frame: Baseline to 6 Weeks
Change in Retardation Factor Scores
Time frame: Baseline to 6 Weeks
Change in Sleep Disturbance Factor Score
Time frame: Baseline to 6 weeks
Change in Verbal Memory Trial Performance Total Score at Endpoint
Time frame: 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 in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
Time frame: 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 in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
Time frame: 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 in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
Time frame: 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 in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Digit Sequencing Task at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Token Motor Task at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Verbal Fluency in Naming Categories at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Verbal Fluency Controlled Word Association at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Symbol Coding at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Tower of London Test at Endpoint
Time frame: Baseline to 6 Weeks LOCF
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
Time frame: 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 in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25012414Keefe 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.
- Derived from this study: PubMed 23609405Gao 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Geodon (Ziprasidone) in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.