Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

This study has been completed.

First Received: March 26, 2004 Last Updated: August 21, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00080327

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Aripiprazole

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

Arms	Assigned Interventions
1: Active Comparator	Drug: Aripiprazole Tablets, Oral, 2mg, Once daily, 6 weeks.
2: Active Comparator	Drug: Aripiprazole Tablets, Oral, 5mg, Once daily, 6 weeks.
3: Active Comparator	Drug: Aripiprazole Tablets, Oral, 10mg, Once daily, 6 weeks.
4: Placebo Comparator	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

Study ID Numbers:	CN138-113 ST
Study First Received:	March 26, 2004
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00080327 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 02, 2009