Bipolar DisorderPhase 3NCT00282464
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With 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 43 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)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 43 sitesUnited States
- Study dates
- Feb 2006to Mar 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 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 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.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Pfizer Investigational Site
Anaheim, California, 92804
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Boca Raton, Florida, 33432
Pfizer Investigational Site
Bradenton, Florida, 34208
Pfizer Investigational Site
Brooklyn, New York, 11223
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
Charlottesville, Virginia, 22903-4895
Pfizer Investigational Site
Chula Vista, California, 91910
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Darien, Connecticut, 06820
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Dothan, Alabama, 36303
Pfizer Investigational Site
Durham, North Carolina, 27704
Pfizer Investigational Site
Eagle, Idaho, 83616
Pfizer Investigational Site
Escondido, California, 92025
Pfizer Investigational Site
Glen Burnie, Maryland, 21061
Pfizer Investigational Site
Granite City, Illinois, 62040-4749
Pfizer Investigational Site
Houston, Texas, 77007
Pfizer Investigational Site
Jacksonville, Florida, 32256-2006
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Little Rock, Arkansas, 77205
Pfizer Investigational Site
Los Angeles, California, 90027-5302
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Olean, New York, 14760
Pfizer Investigational Site
Orange City, Florida, 32763
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19149
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92126
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Scranton, Pennsylvania, 18503
Pfizer Investigational Site
St Louis, Missouri, 63118
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Towson, Maryland, 21204
Pfizer Investigational Site
Tulsa, Oklahoma, 74135
About this study
Official title: 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.
- Conditions
- Bipolar Disorder
- Being tested
- Placebo, Geodon (Ziprasidone)
- Keywords
- Bipolar I Depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.
Geodon (Ziprasidone)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone 20 and 60mg | Active comparator | 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). 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. 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.
Measured: Baseline to Week 6
Secondary outcomes (21)
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
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)
Measured: Baseline to Week 6
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 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.
Measured: Baseline to Week 3, Week 6
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
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.
Measured: Week 1 to Week 6
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
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.
Measured: Week 3, Week 6
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
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
Measured: Baseline to Weeks 3, 6
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
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.
Measured: Baseline to Weeks 3, 6
Change in Bech Melancholia Score
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.
Measured: Baseline to Weeks 3, 6
Change in Anxiety/Somatizations Factor Total Score
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.
Measured: Baseline to Weeks 3, 6
Change in Retardation Factor Scores
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.
Measured: Baseline to Weeks 3, 6
Change in Sleep Disturbance Factor Score
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.
Measured: Baseline to Weeks 3, 6
Change in Hamilton Anxiety Rating (HAM-A)
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.
Measured: Baseline to Weeks 3, 6
Change in Total Score of Young Mania Rating Scale (YMRS)
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.
Measured: Baseline to week 6
Change in Global Clinical Severity of Symptoms (CGI-S)
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
Measured: Baseline to week 6
Change in Global Clinical Improvement of Symptoms (CGI -I)
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
Measured: Baseline to Week 6
Change in Global Assessment of Functioning (GAF)
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.
Measured: Baseline to week 6 (Endpoint)
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
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.
Measured: Baseline to week 6 (endpoint)
Change in Sheehan Disability Scale (SDS) Total Score
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.
Measured: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
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)
Measured: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
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.
Measured: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
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.
Measured: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
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.
Measured: Baseline to Week 6 (endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2008
- Study completionMar 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 (1)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
- 392 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
- NCT00282464
- Sponsor's protocol ID
- A1281139
- Status last verified
- Mar 2021
- First submitted
- 24 Jan 2006
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23609405
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00282464
- Acronym / sponsor ID
- A1281139
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Jan 2006 (estimated)
- Results
- Posted 2 Jun 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone 20 and 60mg | Active comparator | Drug: Geodon (Ziprasidone)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). |
| 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 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 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.
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 |
|---|---|---|
| PlaceboSubjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid. | Drug | Placebo |
| Geodon (Ziprasidone)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). | Drug | Ziprasidone 20 and 60mg |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Week 6
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.
21 secondary outcomes
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
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
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Time frame: Week 1 to Week 6
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
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Time frame: Baseline to Weeks 3, 6
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Time frame: Baseline to Weeks 3, 6
Change in Bech Melancholia Score
Time frame: Baseline to Weeks 3, 6
Change in Anxiety/Somatizations Factor Total Score
Time frame: Baseline to Weeks 3, 6
Change in Retardation Factor Scores
Time frame: Baseline to Weeks 3, 6
Change in Sleep Disturbance Factor Score
Time frame: Baseline to Weeks 3, 6
Change in Hamilton Anxiety Rating (HAM-A)
Time frame: Baseline to Weeks 3, 6
Change in Total Score of Young Mania Rating Scale (YMRS)
Time frame: Baseline to week 6
Change in Global Clinical Severity of Symptoms (CGI-S)
Time frame: Baseline to week 6
Change in Global Clinical Improvement of Symptoms (CGI -I)
Time frame: Baseline to Week 6
Change in Global Assessment of Functioning (GAF)
Time frame: Baseline to week 6 (Endpoint)
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
Time frame: Baseline to week 6 (endpoint)
Change in Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
Time frame: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
Time frame: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
Time frame: Baseline to week 6 (endpoint)
Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
Time frame: Baseline to Week 6 (endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
43 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 43 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 29 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 43 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 2 Jun 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 Week 6). 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 NCT00282464, which also lists 1 linked publication.
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 29 Mar 2021.