Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Otsuka

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease; Dementia

Treatments: Drug: Aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095719

CN138-131

Details and patient eligibility

About

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

Sex: All

Ages: 55 to 95 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

125 participants in 2 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Aripiprazole

B1

Placebo Comparator group

Treatment:

Drug: Placebo