MedDataX Logo

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

NCT ID: NCT00508157

Last Updated: 2013-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

B

Group Type ACTIVE_COMPARATOR

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aripiprazole

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

Intervention Type DRUG

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abilify BMS-337039

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bristol-Myers Squibb

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Brussels, , Belgium

Site Status

Local Institution

Brno, , Czechia

Site Status

Local Institution

Brno, , Czechia

Site Status

Local Institution

Havířov, , Czechia

Site Status

Local Institution

Hradec Králové, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Přerov, , Czechia

Site Status

Local Institution

Roudnice nad Labem, , Czechia

Site Status

Local Institution

Fains-Véel, , France

Site Status

Local Institution

Lille, , France

Site Status

Local Institution

Limoges, , France

Site Status

Local Institution

Montpellier, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Poitiers, , France

Site Status

Local Institution

Strasbourg, , France

Site Status

Local Institution

Ellwangen, , Germany

Site Status

Local Institution

Werneck, , Germany

Site Status

Local Institution

Chania-Crete, , Greece

Site Status

Local Institution

Corfu, , Greece

Site Status

Local Institution

Budapest, , Hungary

Site Status

Local Institution

Gyula, , Hungary

Site Status

Local Institution

Oviedo, Principality of Asturias, Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Wetzikon, , Switzerland

Site Status

Local Institution

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Denmark Finland Norway Poland Sweden Belgium Czechia France Germany Greece Hungary Spain Switzerland Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eudract Number: 2007 001217 42

Identifier Type: -

Identifier Source: secondary_id

CN138-489

Identifier Type: -

Identifier Source: org_study_id