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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: United States: Food and Drug Administration

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 October 21, 2016