Side Effects of Newer Antipsychotics in Older Adults

NCT ID: NCT00245206

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

Detailed 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.

Conditions

Schizophrenia; Alzheimer's Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Risperdal

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.

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.

3: Aripiprazole

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.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.

4: Olanzapine

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.

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.

Interventions

Aripiprazole

Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.

Intervention Type: DRUG

Olanzapine

Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.

Intervention Type: DRUG

Risperidone

Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.

Intervention Type: DRUG

Other Intervention Names

Risperidal

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Dilip V. Jeste

Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilip V. Jeste, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

References

Jin H, Shih PA, Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization. J Clin Psychiatry. 2013 Jan;74(1):10-8. doi: 10.4088/JCP.12m08001. Epub 2012 Nov 27.

Reference Type: DERIVED

PMID: 23218100 (View on PubMed)

Jin H, Meyer J, Mudaliar S, Henry R, Khandrika S, Glorioso DK, Kraemer H, Jeste D. Use of clinical markers to identify metabolic syndrome in antipsychotic-treated patients. J Clin Psychiatry. 2010 Oct;71(10):1273-8. doi: 10.4088/JCP.09m05414yel.

Reference Type: DERIVED

PMID: 21062616 (View on PubMed)

Other Identifiers

DATR A5-ETSE

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01MH071536

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH071536

Identifier Type: NIH

Identifier Source: org_study_id

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