ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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




Links to all studies - primarily for crawlers