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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

NCT ID: NCT00080327

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-09-30

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Tablets, Oral, 2mg, Once daily, 6 weeks.

2

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Tablets, Oral, 5mg, Once daily, 6 weeks.

3

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Tablets, Oral, 10mg, Once daily, 6 weeks.

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 0mg, Once daily, 6 weeks.

Interventions

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Aripiprazole

Tablets, Oral, 2mg, Once daily, 6 weeks.

Intervention Type DRUG

Aripiprazole

Tablets, Oral, 5mg, Once daily, 6 weeks.

Intervention Type DRUG

Aripiprazole

Tablets, Oral, 10mg, Once daily, 6 weeks.

Intervention Type DRUG

Placebo

Tablets, Oral, 0mg, Once daily, 6 weeks.

Intervention Type DRUG

Other Intervention Names

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Abilify Abilify Abilify

Eligibility Criteria

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Inclusion Criteria

* Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Bristol-Meyers Squibb Call Center

Wallingford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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CN138-113 ST

Identifier Type: -

Identifier Source: org_study_id