Clinical trial NCT02960763: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Official title: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment Resistant Depression
Major Depressive Disorder
Treatment-Refractory Depression
Late Life Depression
Geriatric Depression
Keywords: Comparative Effectiveness Research
Pragmatic Clinical Trials
Patient-Centered Outcomes Research
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2016-11-10
Enrollment: 742
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Psychological Well-Being
timeFrame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
measure: Number of Participants With Remission From Depression
timeFrame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
measure: Serious Adverse Events
timeFrame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Late-Life Mood, Stress, and Wellness Research Program
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine Healthy Mind Lab
state: Missouri
city: New York
country: United States
facility: Columbia University Adult and Late Life Depression Clinic
state: New York
city: Pittsburgh
country: United States
facility: UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
state: Pennsylvania
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Washington University School of Medicine
name: Eric Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References: