Text Size

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00080327
First received: March 26, 2004
Last updated: April 7, 2011
Last verified: August 2008
History of Changes
  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
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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080327

Locations
United States, Connecticut
Bristol-Meyers Squibb Call Center
Wallingford, Connecticut, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00080327     History of Changes
Other Study ID Numbers: CN138-113 ST
Study First Received: March 26, 2004
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013