CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 742 enrolled
Drug / intervention
Aripiprazole Augmentation +4 moredrug
Likely dose
Aripiprazole Augmentation 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02960763
NCT02960763Phase 4Completed
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Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

Washington University School of Medicine·interventional·Posted Nov 10, 2016·Updated Oct 3, 2024

In Brief

A Phase 4 clinical trial evaluating Aripiprazole Augmentation, Bupropion Augmentation, and 3 other interventions for Treatment Resistant Depression and 4 related conditions. Completed, enrolled 742 participants across 5 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression, Late Life Depression, Geriatric Depression
CountriesCanada, United States
CollaboratorsPatient-Centered Outcomes Research Institute, National Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 10, 2016
Enrollment StartFeb 24, 2017
Primary CompletionSep 28, 2020
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.6 years ago

Interventions

Aripiprazole Augmentationdrug

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.

Bupropion Augmentationdrug

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.

Switch to bupropiondrug

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.

Lithium Augmentationdrug

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

Switch to nortriptylinedrug

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