Who is sponsoring NCT00508157?

NCT00508157 is sponsored by Bristol-Myers Squibb.

What condition does NCT00508157 study?

NCT00508157 studies Metabolic Syndrome, Schizophrenia.

What drugs are being tested in NCT00508157?

Interventions: Aripiprazole, Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine).

What is the status of NCT00508157?

NCT00508157 is currently TERMINATED.

Last reviewed 2013-11-20 · How we verify

A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

NCT00508157 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 4
Status	TERMINATED
Enrolment	125
Start date	2007-11
Completion	2009-03

Conditions

Metabolic Syndrome
Schizophrenia

Interventions

Aripiprazole
Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

Primary outcomes

Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16 — Baseline, Week 16
Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.

Countries

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