Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00095719
First received: November 9, 2004
Last updated: November 7, 2013
Last verified: August 2008
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00095719     History of Changes
Other Study ID Numbers: CN138-131
Study First Received: November 9, 2004
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014