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A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

NCT00508157 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2013-12-13

Study results available
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Summary

258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

Conditions

Interventions

DRUG

Aripiprazole

Tablets, Oral, 5 to 30 mg, once daily, 16 weeks

DRUG

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

Tablets, Oral, According to summary of product characteristics (SmPC)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00508157 on ClinicalTrials.gov