Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Condition: Treatment Resistant Depression; Major Depressive Disorder; Treatment-Refractory Depression; Late Life Depression; Geriatric Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Aripiprazole Augmentation; Bupropion Augmentation; Switch to bupropion; Lithium Augmentation; Switch to nortriptyline
Intervention description: 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.; 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.; 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.; Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.; 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
Intervention MeSH terms: Aripiprazole; Lithium Carbonate; Bupropion; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 742.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Comparative Effectiveness Research; Pragmatic Clinical Trials; Patient-Centered Outcomes Research

Summary:

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

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