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Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00095524
Enrollment
300
Registered
2004-11-08
Start date
2004-03-31
Completion date
2006-08-31
Last updated
2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight Change, Psychotic Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

Patient weight change, changes in metabolic status

Brief summary

The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.

Interventions

DRUGAripiprazole

Sponsors

Otsuka America Pharmaceutical
CollaboratorINDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

Design outcomes

Primary

MeasureTime frame
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine

Secondary

MeasureTime frame
Assessment of metabolic laboratory measures

Countries

Brazil, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026