Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

370

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Wallingford, Connecticut, United States
        • Bristol-Meyers Squibb Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Active Comparator: 1
Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Placebo Comparator: 4
Drug: Placebo
Tablets, Oral, 0mg, Once daily, 6 weeks.
Active Comparator: 3
Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
Other Names:
  • Abilify
Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change at endpoint in schizophrenia rating scale

Secondary Outcome Measures

Outcome Measure
Clinical Global Improvement scale at endpoint and time to response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

March 26, 2004

First Submitted That Met QC Criteria

March 29, 2004

First Posted (Estimate)

March 30, 2004

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-113 ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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