Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia - Full Text View

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

This study has been completed.

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

MedlinePlus related topics:

Schizophrenia

Drug Information available for:

Aripiprazole

U.S. FDA Resources

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

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

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

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

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Psychotic Disorders

Aripiprazole

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008