Side Effects of Newer Antipsychotics in Older Adults

Veterans Medical Research Foundation

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease; Schizophrenia; Dementia

Treatments: Drug: Aripiprazole; Drug: Olanzapine; Drug: Risperidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00245206

DATR A5-ETSE (Registry Identifier)

R01MH071536 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.

Full description

Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.

Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.

Enrollment: 406 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 3 patient groups

1: Risperdal

Experimental group

Description:

Participants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

Treatment:

Drug: Risperidone

3: Aripiprazole

Experimental group

Description:

Participants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

Treatment:

Drug: Aripiprazole

4: Olanzapine

Experimental group

Description:

Participants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

Treatment:

Drug: Olanzapine