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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: March 26, 2004
Last updated: November 7, 2013
Last verified: August 2008
A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Condition Intervention Phase
Drug: Aripiprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Change at endpoint in schizophrenia rating scale

Secondary Outcome Measures:
  • Clinical Global Improvement scale at endpoint and time to response

Estimated Enrollment: 370
Study Start Date: November 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
Other Name: Abilify
Active Comparator: 2 Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
Other Name: Abilify
Active Comparator: 3 Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
Other Name: Abilify
Placebo Comparator: 4 Drug: Placebo
Tablets, Oral, 0mg, Once daily, 6 weeks.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
  Contacts and Locations
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Please refer to this study by its identifier: NCT00080327

United States, Connecticut
Bristol-Meyers Squibb Call Center
Wallingford, Connecticut, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
  More Information

Additional Information: Identifier: NCT00080327     History of Changes
Other Study ID Numbers: CN138-113 ST
Study First Received: March 26, 2004
Last Updated: November 7, 2013

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017