← Back to Search

Atypical Antidepressant

Switch to Bupropion for Major Depressive Disorder (OPTIMUM Trial)

Phase 4
Waitlist Available
Led By Eric Lenze, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 24 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).

Eligible Conditions
  • Geriatric Depression
  • Major Depressive Disorder
  • Depression
  • Late-Life Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Remission From Depression
Psychological Well-Being
Serious Adverse Events
Secondary study objectives
Change in episodic memory
Change in executive function
Change in executive-control and cortico-limbic circuitry
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Switch to NortriptylineExperimental Treatment1 Intervention
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.
Group II: Switch to BupropionExperimental Treatment1 Intervention
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Group III: Lithium AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Group IV: Bupropion AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Group V: Aripiprazole AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion Augmentation
2017
Completed Phase 4
~750
Switch to bupropion
2017
Completed Phase 4
~750
Aripiprazole Augmentation
2017
Completed Phase 4
~750
Lithium Augmentation
2017
Completed Phase 4
~750
Switch to nortriptyline
2017
Completed Phase 4
~750

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,984 Previous Clinical Trials
2,290,978 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
572 Previous Clinical Trials
27,076,859 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,892 Previous Clinical Trials
2,721,985 Total Patients Enrolled
~86 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top