Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

Washington University School of Medicine742 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

742

Conditions

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

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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 * Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher Exclusion Criteria: * Inability to provide informed consent * Dementia * Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms * High risk for suicide and unable to be managed safely in the clinical trial * Contraindication to proposed study medications, as determined by study physician including history of intolerance or non-response to proposed medications. * Non-correctable, clinically significant sensory impairment interfering with participation * Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. * Moderate to severe substance or alcohol use disorder

Locations (5)

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

Los Angeles, California, United States

Washington University School of Medicine Healthy Mind Lab

St Louis, Missouri, United States

Columbia University Adult and Late Life Depression Clinic

New York, New York, United States

UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Psychological Well-Being

Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10).

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

Number of Participants With Remission From Depression

Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

Serious Adverse Events

Life threatening illness, hospitalization, or need of medical care.

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

Data from ClinicalTrials.gov

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