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COMPLETEDPhase 4NCT02960763

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

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

Lead sponsor: Washington University School of Medicine•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Washington University School of Medicine

Collaborators

Patient-Centered Outcomes Research Institute
National Institute of Mental Health (NIMH)

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.

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 3, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment742

Start dateFeb 2017

Last updatedOct 3, 2024

Condition

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

Locations shown

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

Los Angeles, California

Washington University School of Medicine Healthy Mind Lab

St Louis, Missouri

Columbia University Adult and Late Life Depression Clinic

New York, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2024Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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