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Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

NCT00396214 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2008-06-04

No results posted yet for this study

Summary

The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.

Conditions

  • Schizophrenia

Interventions

DRUG

Bifeprunox

52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.

DRUG

Quetiapine

Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.

DRUG

Bifeprunox

52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Czechia
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Peru
  • Slovakia
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396214 on ClinicalTrials.gov