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

• Status: Active, not recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Aripiprazole; Bupropion; Lithium Carbonate; Nortriptyline

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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