Side Effects of Newer Antipsychotics in Older Adults

Schizophrenia Clinical Trial

Official title:

Metabolic Effects of Newer Antipsychotics in Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245206
• Other study ID #: R01MH071536
• Secondary ID: DATR A5-ETSER01M
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Est. completion date: October 2010

Study information

• Verified date: December 2018
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Schizophrenia

Intervention

Drug:
• Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
• Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
• Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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