Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

NCT00366704 | Terminated Phase 3

• 2 other identifiers: 3168A1-313B3101009
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 66

Brief Summary

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be the change from baseline on body weight at the final evaluation.

  8 weeks

Secondary Outcomes (1)

• Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.

  8 weeks

Study Arms (2)

A

EXPERIMENTAL

Drug: bifeprunox

B

ACTIVE COMPARATOR

Drug: risperidone

Interventions

bifeprunox DRUG

.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)

A

risperidone DRUG

4mg, QD, 8 week treatment

B

Eligibility Criteria

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

You may qualify if:

• Current treatment of at least 3 months with risperidone.
• Primary diagnosis of schizophrenia.
• Total Positive and Negative Symptoms Scale (PANSS) score \< or = 70 at screening and baseline.

You may not qualify if:

• Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
• History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
• History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (66)

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Little Rock, Arkansas, 72201, United States

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Little Rock, Arkansas, 72211, United States

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Anaheim, California, 92802, United States

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Anaheim, California, 92804, United States

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Anaheim, California, 92805, United States

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Boynton Beach, California, 33426, United States

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Costa Mesa, California, 92363, United States

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Costa Mesa, California, 92627, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91206, United States

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Huntington Beach, California, 92648, United States

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La Mesa, California, 91942, 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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Paramount, California, 90723, United States

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Rosemead, California, 91770, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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San Diego, California, 92126, United States

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Santa Ana, California, 92701, United States

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Santa Ana, California, 92705, United States

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New London, Connecticut, 06320, United States

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Fort Lauderdale, Florida, 33319, United States

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Jacksonville, Florida, 32256, United States

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North Miami, Florida, 33161, United States

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St. Petersburg, Florida, 33711, United States

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Atlanta, Georgia, 30307, United States

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Atlanta, Georgia, 30308, United States

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Augusta, Georgia, 30912, United States

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Marietta, Georgia, 30060, United States

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Coevr d'Alene, Idaho, 83814, United States

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Chicago, Illinois, 60631, United States

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Hoffman Estates, Illinois, 60194, United States

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Joliet, Illinois, 60077, United States

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Naperville, Illinois, 60540, United States

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Lake Charles, Louisiana, 70601, United States

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Gaithersburg, Maryland, 20877, United States

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Pittsfield, Massachusetts, 01201, United States

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Worcester, Massachusetts, 01605, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63110, 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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North Platte, Nebraska, 69101, 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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Rochester, New York, 14624, United States

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Staten Island, New York, 10312, United States

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Butner, North Carolina, 27509, United States

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Morehead City, North Carolina, 28557, United States

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Beachwood, Ohio, 44122, United States

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Cleveland, Ohio, 44109, United States

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Oklahoma City, Oklahoma, 73139, United States

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East Stroudsberg, Pennsylvania, 18301, United States

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Jenkintown, Pennsylvania, 19046, United States

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Norristown, Pennsylvania, 19401, United States

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Philadelphia, Pennsylvania, 19149, United States

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Pittsburgh, Pennsylvania, 15108, United States

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Cordova, Tennessee, 38018, United States

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Memphis, Tennessee, 38105, United States

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Memphis, Tennessee, 38157, United States

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Austin, Texas, 78756, United States

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DeSoto, Texas, 75115, United States

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Irving, Texas, 75062, United States

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San Antonio, Texas, 78229, United States

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MeSH Terms

Conditions

Schizophrenia

Interventions

bifeprunox; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 11, 2013

Record last verified: 2008-04

Locations

US (66)