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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00080327
First Posted: March 30, 2004
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Condition Intervention Phase
Schizophrenia Drug: Aripiprazole Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080327


Locations
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:
ClinicalTrials.gov Identifier: NCT00080327     History of Changes
Other Study ID Numbers: CN138-113 ST
First Submitted: March 26, 2004
First Posted: March 30, 2004
Last Update Posted: November 11, 2013
Last Verified: August 2008

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs