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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00280566

First received: January 19, 2006

Last updated: January 5, 2010

Last verified: January 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Bipolar Mania Bipolar Disorder	Drug: Placebo Drug: Ziprasidone Oral Capsule	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to Intervention for a Mood Episode During Double Blind Period [ Time Frame: Period 2: 24 weeks or time of early termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Discontinuation for Any Reason During Double Blind Period 2 [ Time Frame: Period 2: 24 weeks or time of early termination ] [ Designated as safety issue: No ]
Modified Time to Intervention for a Mood Episode (TIME) [ Time Frame: Period 2: Week 24 or time of early termination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	584
Study Start Date:	December 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ziprasidone Active treatment, double-blind, randomized arm	Drug: Ziprasidone Oral Capsule 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. Other Name: Geodon, Zeldox
Placebo Comparator: Placebo Placebo treatment, double-blind, randomized arm	Drug: Placebo 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.

Arms

Assigned Interventions

Experimental: Ziprasidone

Active treatment, double-blind, randomized arm

Drug: Ziprasidone Oral Capsule

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.

Other Name: Geodon, Zeldox

Placebo Comparator: Placebo

Placebo treatment, double-blind, randomized arm

Drug: Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280566

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Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35924
Pfizer Investigational Site
Birmingham, Alabama, United States, 35226
United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72223
United States, California
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
Pfizer Investigational Site
Los Angeles, California, United States, 90026
Pfizer Investigational Site
National City, California, United States, 91950
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Sacramento, California, United States, 95823
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San Diego, California, United States, 92108
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Temecula, California, United States, 92590
Pfizer Investigational Site
Temecula, California, United States, 92591
United States, Florida
Pfizer Investigational Site
Altamonte Springs, Florida, United States, 32701
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Fort Lauderdale, Florida, United States, 33319
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Fort Myers, Florida, United States, 33912
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Jacksonville, Florida, United States, 32216
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Maitland, Florida, United States, 32751
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Miami, Florida, United States, 33016
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Miami, Florida, United States, 33126
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North Miami, Florida, United States, 33161
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Orlando, Florida, United States, 32806
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Tavares, Florida, United States, 32778
United States, Georgia
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Decatur, Georgia, United States, 30033
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Smyrna, Georgia, United States, 30080
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96826
United States, Illinois
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Des Plaines, Illinois, United States, 60016
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Libertyville, Illinois, United States, 60048
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Naperville, Illinois, United States, 60540
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Naperville, Illinois, United States, 60563
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Oak Brook, Illinois, United States, 60523
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Schaumburg, Illinois, United States, 60194
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kansas
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Topeka, Kansas, United States, 66606
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Wichita, Kansas, United States, 67207
United States, Kentucky
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Lexington, Kentucky, United States, 40509
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Owensboro, Kentucky, United States, 42301
United States, Maryland
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Baltimore, Maryland, United States, 21285
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Rockville, Maryland, United States, 20852
United States, Massachusetts
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
Pfizer Investigational Site
Taunton, Massachusetts, United States, 02780
United States, Mississippi
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Olive Branch, Mississippi, United States, 38654
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Ridgeland, Mississippi, United States, 39157
United States, Missouri
Pfizer Investigational Site
St. Charles, Missouri, United States, 63301
United States, Nebraska
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Lincoln, Nebraska, United States, 68506
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Las Vegas, Nevada, United States, 89106
United States, New Hampshire
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Nashua, New Hampshire, United States, 03060
United States, New Jersey
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Paramus, New Jersey, United States, 07652
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Teaneck, New Jersey, United States, 07666
United States, New York
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Buffalo, New York, United States, 14215
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Olean, New York, United States, 14760
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0559
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
Pfizer Investigational Site
Toledo, Ohio, United States, 43609
United States, Oklahoma
Pfizer Investigational Site
Bethany, Oklahoma, United States, 73008
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73116
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38117
United States, Texas
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Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78756
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Bellaire, Texas, United States, 77401
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Dallas, Texas, United States, 75390-9121
Pfizer Investigational Site
Dallas, Texas, United States, 75231
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DeSoto, Texas, United States, 75115
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Houston, Texas, United States, 77054
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Houston, Texas, United States, 77057
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Houston, Texas, United States, 77008
Chile
Pfizer Investigational Site
Santiago, RM, Chile
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Santiago, Chile
France
Pfizer Investigational Site
Angouleme, France, 16000
Pfizer Investigational Site
Brest Naval, France, 29240
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Douai, France, 59500
Pfizer Investigational Site
Mulhouse, France, 68100
Germany
Pfizer Investigational Site
Berlin, Germany, 14050
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Berlin, Germany, 13509
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Cham, Germany, 93413
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Essen, Germany, 45136
Guatemala
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Ciudad de Guatemala, Guatemala
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Guatemala, Guatemala
Hong Kong
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New Territories, Hong Kong
India
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Ellisbridge, Ahmedabad, India, 380 006
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Tirupati, Andhra Pradesh, India, 517 507
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 010
Pfizer Investigational Site
Mysore, Karnataka, India, 570004
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Chennai, Tamil Nadu, India, 600 003
Pfizer Investigational Site
Ludhiana, India, 141001
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Pune, India, 411 030
Italy
Pfizer Investigational Site
Catania, Italy, 95123
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Firenze, Italy, 50134
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Parma, Italy, 43100
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Pisa, Italy, 56126
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 03740
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Zapopan, Jalisco, Mexico, 45200
Russian Federation
Pfizer Investigational Site
Arkhangelskaya Obl, Primorsky Raion, Russian Federation, 163530
Pfizer Investigational Site
Khotkovo, Russian Federation, 141371
Spain
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Barcelona, Spain, 08036
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Barcelona, Spain, 08019
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Madrid, Spain, 28007
Taiwan
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Taipei, Taiwan, 110
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Taipei, Taiwan, 112
Venezuela
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela, 1010
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela, 1050

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Jan 26.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00280566 History of Changes
Other Study ID Numbers:	A1281137
Study First Received:	January 19, 2006
Results First Received:	May 6, 2009
Last Updated:	January 5, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013

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