3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

NCT00312494 | Completed Phase 3 Results

• 1 other identifier: A1281143
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 66

Brief Summary

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)

  YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).

  Baseline, Week 3

Secondary Outcomes (8)

• Change From Baseline to Week 1 and Week 2 in YMRS

  Baseline, Week 1, Week 2

• Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores

  Baseline, Week 1, Week 2, Week 3

• Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score

  Baseline, Week 1, Week 2, Week 3

• Clinical Global Impression - Improvement (CGI-I) Scale Scores

  Week 1, Week 2, Week 3

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score

  Baseline, Week 3

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Ziprasidone 20-40mg twice a day (BID)

EXPERIMENTAL

Drug: Ziprasidone

Ziprasidone 60-80mg BID

EXPERIMENTAL

Drug: Ziprasidone

Interventions

Placebo DRUG

Placebo with mood stabilizer (either lithium or divalproex)

Placebo

Ziprasidone DRUG

Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)

Also known as: Geodon, Zeldox

Ziprasidone 20-40mg twice a day (BID)

Eligibility Criteria

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

You may qualify if:

• Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
• At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
• Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

You may not qualify if:

• Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
• Subjects with other DSM-IV-TR Axis I or Axis II disorders (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.

Sponsors & Collaborators

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

Study Sites (66)

Pfizer Investigational Site

Dothan, Alabama, 36303, United States

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Pfizer Investigational Site

Scottsdale, Arizona, 85251, United States

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Little Rock, Arkansas, 72211, United States

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Cerritos, California, 90703, United States

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Costa Mesa, California, 92626, United States

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Escondido, California, 92025, United States

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Glendale, California, 91204, United States

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Huntington Beach, California, 92647, United States

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Los Angeles, California, 90057, United States

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Los Angeles, California, 90061, United States

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National City, California, 91950, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92114, United States

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San Diego, California, 92120, United States

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San Diego, California, 92126, United States

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Torrance, California, 90505, United States

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Hartford, Connecticut, 06106, United States

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New Britain, Connecticut, 06050, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33301, United States

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Fort Lauderdale, Florida, 33308, United States

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Gainesville, Florida, 32607, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32256-2006, United States

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Lauderhill, Florida, 33119, United States

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North Miami, Florida, 33161, United States

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Atlanta, Georgia, 30308, United States

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Honolulu, Hawaii, 96813, United States

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Des Plaines, Illinois, 60016, United States

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Hoffman Estates, Illinois, 60169, United States

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Hoffman Estates, Illinois, 60194, United States

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Schaumburg, Illinois, 60194, United States

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Greenwood, Indiana, 46143, United States

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Prairie Village, Kansas, 66206, United States

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Glen Burnie, Maryland, 21061, United States

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Flowood, Mississippi, 39232, United States

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Kansas City, Missouri, 64133, United States

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Saint Charles, Missouri, 63304, United States

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St Louis, Missouri, 63044-2588, United States

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St Louis, Missouri, 63118, United States

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St Louis, Missouri, 63128, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89103, United States

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Clementon, New Jersey, 08021, United States

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Princeton, New Jersey, 08540, United States

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Amityville, New York, 11701, United States

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Buffalo, New York, 14215, United States

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Cedarhurst, New York, 11516, United States

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Elmsford, New York, 10523, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45220, United States

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Cincinnati, Ohio, 45267-0559, United States

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Cleveland, Ohio, 44113, United States

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Oklahoma City, Oklahoma, 73112, United States

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Philadelphia, Pennsylvania, 19149, United States

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Charleston, South Carolina, 29405, United States

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Dallas, Texas, 75228, United States

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Irving, Texas, 75062, United States

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Plano, Texas, 75024, United States

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San Antonio, Texas, 78229-3900, United States

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San Antonio, Texas, 78259-3509, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23230, United States

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Pfizer Investigational Site

Bellevue, Washington, 98004, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98033, United States

Location

Related Publications (2)

• Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.

  PMID: 23218158 DERIVED

• Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.

  PMID: 23218157 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: April 6, 2006
• First Posted: April 10, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 29, 2021
• Results First Posted: January 22, 2010

Record last verified: 2021-03

Locations

US (66)