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Aripiprazole Oral Acceptability Trial

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ClinicalTrials.gov Identifier: NCT00101569
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Oral Acceptability Trial
Study Start Date : March 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A1 Drug: Aripiprazole
Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
Other Name: Abilify
Experimental: A2 Drug: Aripiprazole
Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
Other Name: Abilify



Primary Outcome Measures :
  1. acceptability


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

Inclusion Criteria:

  • Stable patients currently receiving aripiprazole or other antipsychotic medications.

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): NCT00101569


Locations
United States, California
Local Institution
Anaheim, California, United States
Local Institution
National City, California, United States
United States, Florida
Local Institution
North Miami Beach, Florida, United States
United States, Kansas
Local Institution
Overland Park, Kansas, United States
United States, New York
Local Institution
Staten Island, New York, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
United States, Virginia
Local Institution
Falls Church, Virginia, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00101569     History of Changes
Other Study ID Numbers: CN138-091
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: July 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