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

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.

Conditions

• Depression
• Dementia
• Mild Cognitive Impairment
• Treatment Resistant Depression
• Major Depressive Disorder
• Treatment-Refractory Depression
• Late Life Depression
• Geriatric Depression

Interventions

DRUG

Aripiprazole Augmentation

Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.

DRUG

Bupropion Augmentation

Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.

DRUG

Switch to bupropion

Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.

DRUG

Lithium Augmentation

Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.

DRUG

Switch to nortriptyline

Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Aristotle Voineskos, MD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2024-07-31

Completion

2024-07-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations