Completed

A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

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What is being tested

Aripiprazole

+ Placebo

Drug
Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

Over 18 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Official TitleA Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
NCT00080327
Principal SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

370 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

1 inclusion criteria required to participate
Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Group III

Active Comparator

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bristol-Meyers Squibb Call Center

Wallingford, United StatesOpen Bristol-Meyers Squibb Call Center in Google Maps
CompletedOne Study Center