Side Effects of Newer Antipsychotics in Older Adults

NCT00245206 | Completed Phase 4 DMC

• 2 other identifiers: R01MH071536DATR A5-ETSE
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Alzheimer's Disease; Dementia

Keywords

Antipsychotic; Diabetes; Hyperlipidemia; Stroke

Outcome Measures

Primary Outcomes (3)

• Change in Body Mass Index

  Change in body mass index (BMI) between each study visit. weight and height will be combined to report BMI in kg/m\^2. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

  Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Change in Fasting Plasma Glucose (FPG)

  Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

  Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Change in LDL cholesterol, HDL cholesterol, and triglycerides

  Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

  Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Study Arms (3)

1: Risperdal

EXPERIMENTAL

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.

Drug: Risperidone

3: Aripiprazole

EXPERIMENTAL

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.

Drug: Aripiprazole

4: Olanzapine

EXPERIMENTAL

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.

Drug: Olanzapine

Interventions

Aripiprazole DRUG

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

3: Aripiprazole

Olanzapine DRUG

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

4: Olanzapine

Risperidone DRUG

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

Also known as: Risperidal

1: Risperdal

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92037, United States

Location

Related Publications (2)

• 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.

  PMID: 23218100 DERIVED

• 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.

  PMID: 21062616 DERIVED

MeSH Terms

Conditions

Schizophrenia; Alzheimer Disease; Dementia; Diabetes Mellitus; Hyperlipidemias; Stroke

Interventions

Aripiprazole; Olanzapine; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Pyrimidinones; Pyrimidines

Study Officials

• Dilip V. Jeste, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: August 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)