RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT)

Completed · Phase 4

Conditions studied: Depression, Dementia, Mild Cognitive Impairment, Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression, Late Life Depression, Geriatric Depression

In brief

The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.

Key facts

Study ID

NCT05531591

Run by

Centre for Addiction and Mental Health

People needed

87

Starts

2019-08-01

Expected to finish

2024-07-31

Last updated by the study team

2024-11-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 60 and older, with approximately equal proportions aged 60-70 and 70+.
• Current Major Depressive Disorder (MDD), single or recurrent, as diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
• Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (approximately 12 weeks).
• PHQ-9 score of 10 or higher.

You may not qualify if…

• Dementia; patients screened out due to possible dementia will be referred to a local Memory Clinic or back to their clinician for evaluation to clarify the presence or absence of dementia.
• Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
• High risk for suicide (e.g. active Suicidal ideations (SI) and or current/recent intent or plan)). Urgent psychiatric referral will be made in these cases.
• Non-correctable, clinically significant sensory impairment (e.g., cannot hear well enough to cooperate with interview).
• Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
• Moderate to severe substance or alcohol use disorder, as determined by study physician.
• Seizure disorder.
• Parkinson's Disease

Where it is running

• UCLA Late-Life Mood, Stress, and Wellness Research Program — Los Angeles, California, United States
• Washington University School of Medicine Healthy Mind Lab — St Louis, Missouri, United States
• Columbia University Adult and Late Life Depression Clinic — New York, New York, United States
• Centre for Addiction and Mental Health — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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