Clinical trial NCT00245206: Side Effects of Newer Antipsychotics in Older Adults
Official title: Metabolic Effects of Newer Antipsychotics in Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Alzheimer's Disease
Dementia
Keywords: Antipsychotic
Diabetes
Hyperlipidemia
Stroke
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-10-27
Enrollment: 406
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Change in LDL cholesterol, HDL cholesterol, and triglycerides
timeFrame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Dilip V. Jeste, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.