Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

NCT00483548 | Completed Phase 3 Results DMC

• 1 other identifier: A1281158
• Study Type: interventional
• Target: 298
• Locations: 3 countries
• Sites: 70

Brief Summary

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Conditions

Bipolar Disorder; Depression, Bipolar

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.

  Baseline, Week 6

Secondary Outcomes (13)

• Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)

  Baseline, Week 6

• MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6

  Week 6

• MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6

  Week 6

• Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6

  Baseline, Week 6

• Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

Other Outcomes (3)

• Change From Baseline in Simpson Angus Scale (SAS) Score

  Baseline, Week 2, Week 4, Week 6

• Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)

  Baseline, Week 2, Week 4, Week 6

• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores

  Baseline, Week 2, Week 4, Week 6

Study Arms (2)

Ziprasidone

EXPERIMENTAL

Active treatment, double-blind, randomized treatment arm

Drug: Ziprasidone

Placebo

PLACEBO COMPARATOR

Inactive, placebo treatment, double-blind, randomized arm

Drug: Placebo

Interventions

Ziprasidone DRUG

Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.

Also known as: Geodon, Zeldox

Ziprasidone

Placebo DRUG

Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

You may not qualify if:

• Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
• Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
• Psychotic symptoms (hallucinations and/or delusions).

Sponsors & Collaborators

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

Study Sites (70)

Pfizer Investigational Site

Chandler, Arizona, 85226, United States

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Litchfield Park, Arizona, 85340, United States

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Little Rock, Arkansas, 72211, United States

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Little Rock, Arkansas, 72223, United States

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Springdale, Arkansas, 72762, United States

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Costa Mesa, California, 92627, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92108, United States

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Torrance, California, 90502, United States

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Boca Raton, Florida, 33486-1340, United States

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Boca Raton, Florida, 33486, United States

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Jacksonville, Florida, 32256-2006, United States

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Orlando, Florida, 32806, United States

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Sanford, Florida, 32771, United States

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St. Petersburg, Florida, 33702, United States

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West Palm Beach, Florida, 33407, United States

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Chicago, Illinois, 60640, United States

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Skokie, Illinois, 60077, United States

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Greenwood, Indiana, 46143, United States

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Indianapolis, Indiana, 46260, United States

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Topeka, Kansas, 66606, United States

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Wichita, Kansas, 67207, United States

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Lake Charles, Louisiana, 70601, United States

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Rockville, Maryland, 20852, United States

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Boston, Massachusetts, 02135, United States

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Watertown, Massachusetts, 02472, United States

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Clinton Township, Michigan, 48038, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63044-2588, United States

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Lincoln, Nebraska, 68510, United States

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Nashua, New Hampshire, 03060, United States

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Cherry Hill, New Jersey, 08002, United States

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Clementon, New Jersey, 08021, United States

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Brooklyn, New York, 11201, United States

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Glen Oaks, New York, 11004, United States

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New York, New York, 10023, United States

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Olean, New York, 14760, United States

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Rochester, New York, 14618, United States

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Staten Island, New York, 10312, United States

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Chapel Hill, North Carolina, 27599, United States

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Cincinnati, Ohio, 45227, United States

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Cincinnati, Ohio, 45267-0516, United States

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Columbus, Ohio, 43210, United States

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Dayton, Ohio, 45408, United States

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Oklahoma City, Oklahoma, 73116, United States

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Oklahoma City, Oklahoma, 73119, United States

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Portland, Oregon, 97210, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19139, United States

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Memphis, Tennessee, 38117, United States

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Austin, Texas, 78754, United States

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Austin, Texas, 78756, United States

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Houston, Texas, 77040, United States

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Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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Charlottesville, Virginia, 22903, United States

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Kirkland, Washington, 98033, United States

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Richland, Washington, 99352, United States

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Seattle, Washington, 98104, United States

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Brown Deer, Wisconsin, 53223, United States

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Westmead, New South Wales, 2145, Australia

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Everton Park, Queensland, 4053, Australia

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Spring Hill, Queensland, 4000, Australia

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Richmond, Victoria, 3121, Australia

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Ellisbridge, Ahmedabad, 380 006, India

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Ahmedabad, Gujarat, 380 006, India

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Aurangabad, Maharashtra, 431005, India

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Pune, Maharashtra, 411 001, India

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Pfizer Investigational Site

Pune, Maharashtra, 411 004, India

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Pfizer Investigational Site

Delhi, New Delhi, 110027, India

Location

Related Publications (1)

• Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.

  PMID: 21672493 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 7, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 10, 2021
• Results First Posted: February 23, 2010

Record last verified: 2021-02

Locations

AU (4); IN (6); US (60)