Clinical trial NCT00508157: A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metabolic Syndrome
Schizophrenia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2007-07-27
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Patients:

* with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at least 3 months
* with diagnosis of metabolic syndrome
* not treated for 1 of the parameters of metabolic syndrome

Primary outcomes:
measure: Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Number of Participants Remaining on Metabolic Syndrome at Week 16
timeFrame: Week 16
measure: Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Mean Change From Baseline for Fasting Glucose Levels Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Mean Change From Baseline in Body Weight Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Median Change From Baseline in Body Mass Index (BMI) Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16
timeFrame: Baseline, Week 4, Week 8,Week 12, Week 16
measure: Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Local Institution
city: Brno
country: Czech Republic
facility: Local Institution
city: Brno
country: Czech Republic
facility: Local Institution
city: Havirov
country: Czech Republic
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Prague
country: Czech Republic
facility: Local Institution
city: Praha 10
country: Czech Republic
facility: Local Institution
city: Praha 6
country: Czech Republic
facility: Local Institution
city: Prerov
country: Czech Republic
facility: Local Institution
city: Roudnice Nad Labem
country: Czech Republic
facility: Local Institution
city: Fains Veel
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Ellwangen
country: Germany
facility: Local Institution
city: Werneck
country: Germany
facility: Local Institution
city: Chania-Crete
country: Greece
facility: Local Institution
city: Corfu
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
state: Asturias
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Wetzikon
country: Switzerland
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: