Overview

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
National Institute of Mental Health (NIMH)
Patient-Centered Outcomes Research Institute
Treatments:
Antidepressive Agents
Aripiprazole
Bupropion
Lithium Carbonate
Nortriptyline
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

- 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