Bipolar ManiaPhase 3NCT00280566

Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

A Phase 3 study testing Ziprasidone Oral Capsule in people with Bipolar Mania and Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 107 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Mania, Bipolar Disorder
What is being tested?: Ziprasidone Oral Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 584 participants
Where: 107 sitesin 13 countries
Study dates: Dec 2005to May 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

Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

Who cannot join

Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome

Trial locations and contacts

107 sites in 13 countries.

Country

City, postcode or hospital

107 sites in 13 countries

United States73 sites

Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Arlington, Texas, 76012
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baltimore, Maryland, 21285
Pfizer Investigational Site
Bellaire, Texas, 77401
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Birmingham, Alabama, 35226
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Birmingham, Alabama, 35924
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Costa Mesa, California, 92626
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75390-9121
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Des Plaines, Illinois, 60016
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Fort Lauderdale, Florida, 33319
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Honolulu, Hawaii, 96826
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Houston, Texas, 77057
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Libertyville, Illinois, 60048
Pfizer Investigational Site
Lincoln, Nebraska, 68506
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Little Rock, Arkansas, 72223
Pfizer Investigational Site
Los Angeles, California, 90026
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Miami, Florida, 33016
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Naperville, Illinois, 60540
Pfizer Investigational Site
Naperville, Illinois, 60563
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Oak Brook, Illinois, 60523
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116
Pfizer Investigational Site
Olean, New York, 14760
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Paramus, New Jersey, 07652
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Ridgeland, Mississippi, 39157
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Rockville, Maryland, 20852
Pfizer Investigational Site
Sacramento, California, 95823
Pfizer Investigational Site
Saint Charles, Missouri, 63301
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Schaumburg, Illinois, 60194
Pfizer Investigational Site
Scottsdale, Arizona, 85251
Pfizer Investigational Site
Smyrna, Georgia, 30080
Pfizer Investigational Site
Taunton, Massachusetts, 02780
Pfizer Investigational Site
Tavares, Florida, 32778
Pfizer Investigational Site
Teaneck, New Jersey, 07666
Pfizer Investigational Site
Temecula, California, 92590
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Toledo, Ohio, 43609
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Wichita, Kansas, 67207

Other trials in United States

India7 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 010
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 003
Pfizer Investigational Site
Ellisbridge, Ahmedabad, 380 006
Pfizer Investigational Site
Ludhiana, 141001
Pfizer Investigational Site
Mysore, Karnataka, 570004
Pfizer Investigational Site
Pune, 411 030
Pfizer Investigational Site
Tirupati, Andhra Pradesh, 517 507

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France4 sites

Pfizer Investigational Site
Angoulême, 16000
Pfizer Investigational Site
Brest Naval, 29240
Pfizer Investigational Site
Douai, 59500
Pfizer Investigational Site
Mulhouse, 68100

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Germany4 sites

Pfizer Investigational Site
Berlin, 13509
Pfizer Investigational Site
Berlin, 14050
Pfizer Investigational Site
Cham, 93413
Pfizer Investigational Site
Essen, 45136

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Italy4 sites

Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Pisa, 56126

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Spain3 sites

Pfizer Investigational Site
Barcelona, 08019
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Madrid, 28007

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Chile2 sites

Pfizer Investigational Site
Santiago, RM
Pfizer Investigational Site
Santiago

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Mexico2 sites

Pfizer Investigational Site
Mexico City, Mexico City, 03740
Pfizer Investigational Site
Zapopan, Jalisco, 45200

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Russia2 sites

Pfizer Investigational Site
Arkhangelskaya Obl, Primorsky Raion, 163530
Pfizer Investigational Site
Khot'kovo, 141371

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Taiwan2 sites

Pfizer Investigational Site
Taipei, 110
Pfizer Investigational Site
Taipei, 112

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Venezuela2 sites

Pfizer Investigational Site
Caracas, Distrito Federal, 1010
Pfizer Investigational Site
Caracas, Distrito Federal, 1050

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Guatemala1 site

Pfizer Investigational Site
Guatemala City

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Hong Kong1 site

Pfizer Investigational Site
New Territories

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About this study

Official title: A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Conditions: Bipolar Mania, Bipolar Disorder
Being tested: Placebo, Ziprasidone Oral Capsule
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
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
Ziprasidone Oral CapsuleDrug
Also called Geodon, Zeldox
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.

Study groups in NCT00280566
Study group	Role	What they receive
Ziprasidone	Experimental	Active treatment, double-blind, randomized arm Receives: Drug: Ziprasidone Oral Capsule
Placebo	Placebo comparator	Placebo treatment, double-blind, randomized arm Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Intervention for a Mood Episode During Double Blind Period
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
Measured: Period 2: 24 weeks or time of early termination

Secondary outcomes (9)

Time to Discontinuation for Any Reason During Double Blind Period 2
Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.
Measured: Period 2: 24 weeks or time of early termination
Modified Time to Intervention for a Mood Episode (TIME)
Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
Measured: Period 2: Week 24 or time of early termination
Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period
Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.
Measured: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.
Measured: Period 2: Weeks 1 - 24 or time of early termination
Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period
Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.
Measured: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.
Measured: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)
Measured: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).
Measured: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).
Measured: Period 2: Weeks 4 - 24 or time of early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005May 2008

First posted23 Jan 2006 (estimated)
Study startDec 2005
Primary completionMay 2008
Study completionMay 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 ManiaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00280566
Sponsor's protocol ID: A1281137
Status last verified: Mar 2021
First submitted: 19 Jan 2006
Last updated: 25 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.
PubMed 20122373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents
ClinicalTrials.gov ID: NCT00280566
Acronym / sponsor ID: A1281137
Conditions: Bipolar Mania, Bipolar Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 584 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 23 Jan 2006 (estimated)
Results: Posted 14 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ziprasidone	Experimental	Drug: Ziprasidone Oral CapsuleActive treatment, double-blind, randomized arm
Placebo	Placebo comparator	Drug: PlaceboPlacebo treatment, double-blind, randomized arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

Key exclusion criteria (1 listed)

Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome

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
PlaceboOral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.	Drug	Placebo
Ziprasidone Oral CapsuleAlso: Geodon, ZeldoxOral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.	Drug	Ziprasidone

Primary outcome

Time to Intervention for a Mood Episode During Double Blind Period
Time frame: Period 2: 24 weeks or time of early termination
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.

9 secondary outcomes

Time to Discontinuation for Any Reason During Double Blind Period 2
Time frame: Period 2: 24 weeks or time of early termination
Modified Time to Intervention for a Mood Episode (TIME)
Time frame: Period 2: Week 24 or time of early termination
Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period
Time frame: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period
Time frame: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period
Time frame: Period 2: Weeks 4 - 24 or time of early termination

Results and safety

Results posted to the registry on 14 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1 Open Label Ziprasidone	584	241
Ziprasidone	0	0
Placebo	0	0

Primary outcome: Time to Intervention for a Mood Episode During Double Blind Period

Time frame: Period 2: 24 weeks or time of early termination. Mean (Standard Error). Unit: Days

Measure	Ziprasidone n = 127	Placebo n = 111
Value	172.159 (5.646)	143.133 (7.532)

Ziprasidone vs Placebo: p = 0.0104, Log Rank

Population analysed: Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1 Open Label Ziprasidone	15 of ?	362 of ?	Not reported
Ziprasidone	3 of ?	22 of ?	Not reported
Placebo	2 of ?	24 of ?	Not reported

Limitations and caveats (from the sponsor): This is a maintenance of effect design using a survival analysis methodology. In such a design it may be difficult to interpret timepoint by timepoint treatment group comparisons in MRS, CGI-S, CGI-I, MADRS, and PANSS.

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 20122373Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.
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

107 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone Oral Capsule in people with Bipolar Mania and Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 107 sites in 13 countries.

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 1 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 107 sites in United States, India, France, Germany, Italy and 8 more countries. 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 14 Dec 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?

Time to Intervention for a Mood Episode During Double Blind Period (time frame: Period 2: 24 weeks or time of early termination). 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 NCT00280566, 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 25 Mar 2021.