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

PHASE4CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
DepressionDementiaMild Cognitive ImpairmentTreatment Resistant DepressionMajor Depressive DisorderTreatment-Refractory DepressionLate Life DepressionGeriatric 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

Trial Locations (4)

10032

Columbia University Adult and Late Life Depression Clinic, New York

63110

Washington University School of Medicine Healthy Mind Lab, St Louis

90095

UCLA Late-Life Mood, Stress, and Wellness Research Program, Los Angeles

M6J 1H4

Centre for Addiction and Mental Health, Toronto

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Centre for Addiction and Mental Health

OTHER

NCT05531591 - RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT) | Biotech Hunter | Biotech Hunter