Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
(OPTIMUM Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byEric Lenze, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Men and women aged 60 and older

Current Major Depressive Disorder (MDD)

Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length

See 1 more

Treatment Details

Interventions

Aripiprazole Augmentation (Atypical Antipsychotic)
Bupropion Augmentation (Atypical Antidepressant)
Lithium Augmentation (Mood Stabilizer)
Switch to bupropion (Atypical Antidepressant)
Switch to nortriptyline (Tricyclic Antidepressant)

Participant Groups

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.