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Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Primary Purpose

Dementia, Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Acute agitation in patients diagnosed with Dementia

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A1

B1

Arm Description

Outcomes

Primary Outcome Measures

tolerability

Secondary Outcome Measures

safety assessments

Full Information

First Posted
November 9, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00095719
Brief Title
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Official Title
A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer's Disease
Keywords
Acute agitation in patients diagnosed with Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
125 (false)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
B1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
tolerability
Secondary Outcome Measure Information:
Title
safety assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Local Institution
City
Hamden
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Midvale
State/Province
Utah
Country
United States

12. IPD Sharing Statement

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Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

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