Phase 4
Completed N=619
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Depression · Major Depressive Disorder · Treatment-Refractory Depression · Late Life Depression
Source: ClinicalTrials.gov NCT02960763 ↗
Enrolled (actual)
619
Serious AEs
8.3%
Results posted
May 2022
Primary outcomePrimary: Psychological Well-Being — 34.7; 35.0; 34.8; 33.1 t-score — p=0.010
◆ Published Evidence
Established
79citations · ~26 / year
Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression.
Summary
The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).
Linked Publications (3)
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Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression.
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Alcohol and substance use in older adults with treatment-resistant depression.
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Cognitive changes in older adults receiving pharmacotherapy for treatment-resistant depression: a secondary analysis of the OPTIMUM randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychological Well-Being |
34.7; 35.0; 34.8; 33.1; 34.2; 38.8 | 0.010 sig |
| PRIMARY Number of Participants With Remission From Depression |
61; 58; 39; 24; 26 | 0.038 sig |
| PRIMARY Serious Adverse Events |
15; 15; 19; 12; 11 | 0.164 |
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
Data sourced from ClinicalTrials.gov (NCT02960763) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.