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

March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

584

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Period 2: 24 weeks or time of early termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discontinuation for Any Reason During Double Blind Period 2
Time Frame: Period 2: 24 weeks or time of early termination
Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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)
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
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).
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
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).
Period 2: Weeks 4 - 24 or time of early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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