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Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095719
First Posted: November 9, 2004
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.

Condition Intervention Phase
Dementia Alzheimer's Disease Drug: Aripiprazole Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • tolerability

Secondary Outcome Measures:
  • safety assessments

Estimated Enrollment: 125
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Aripiprazole
IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.
Other Name: Abilify
Placebo Comparator: B1 Drug: Placebo
IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia.

Exclusion Criteria:

  • Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.
  Contacts and Locations
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): NCT00095719


Locations
United States, California
Local Institution
Santa Ana, California, United States
United States, Connecticut
Local Institution
Hamden, Connecticut, United States
United States, Florida
Local Institution
Hialeah, Florida, United States
Local Institution
Miami, Florida, United States
Local Institution
North Miami, Florida, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, New York
Local Institution
New York, New York, United States
Local Institution
Staten Island, New York, United States
United States, Ohio
Local Institution
Dayton, Ohio, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
Local Institution
Tulsa, Oklahoma, United States
United States, Pennsylvania
Local Institution
Hershey, Pennsylvania, United States
United States, Texas
Local Institution
Austin, Texas, United States
United States, Utah
Local Institution
Midvale, Utah, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00095719     History of Changes
Other Study ID Numbers: CN138-131
First Submitted: November 9, 2004
First Posted: November 9, 2004
Last Update Posted: November 11, 2013
Last Verified: August 2008

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Acute agitation in patients diagnosed with Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs