NCT02960763

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 742 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy. * Adding aripiprazole to current antidepressant medication * Adding bupropion to current antidepressant medication * Replacing current antidepressant medication with bupropion If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy: * Adding lithium to current antidepressant medication * Replacing current antidepressant medication with nortriptyline All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance. After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months. Participants in this clinical trial will also be asked to participate in an additional study to gather imaging and biomarker data.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder
• Treatment-Refractory Depression
• Late Life Depression
• Geriatric Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-24
• Primary completion: 2020-09-28
• Completion: 2021-09-01
• First posted: 2016-11-10
• Last updated: 2024-10-03
• Results posted: 2022-05-24

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study