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Completed

NCT Number: NCT02960763

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).

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Geriatric Depression Late Life Depression Major Depressive Disorder Mental Disorders Mood Disorders Treatment-Refractory Depression

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole Augmentation

Drug

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.

Other names: Abilify

Bupropion Augmentation

Drug

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.

Other names: Wellbutrin

Switch to bupropion

Drug

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.

Other names: Wellbutrin

Lithium Augmentation

Drug

Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.

Other names: Lithium carbonate, Eskalith

Switch to nortriptyline

Drug

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

Other names: Pamelor,

Primary outcomes

  1. Psychological Well-Being

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

    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).

  2. Number of Participants With Remission From Depression

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

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

  3. Serious Adverse Events

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

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Acronym: OPTIMUM

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 10, 2016
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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