Phase 4
N=619
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Treatment Resistant Depression · Major Depressive Disorder · Treatment-Refractory Depression · Late Life Depression · Geriatric Depression
Bottom Line
View on ClinicalTrials.gov: NCT02960763 ↗Enrolled (actual)
619
Serious AEs
8.3%
Results posted
May 2022
Primary outcome: Primary: Psychological Well-Being — 34.7; 35.0; 34.8; 33.1 t-score — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aripiprazole Augmentation (Drug); Bupropion Augmentation (Drug); Switch to bupropion (Drug); Lithium Augmentation (Drug); Switch to nortriptyline (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Sep 2020
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 |
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
Data sourced from ClinicalTrials.gov (NCT02960763). 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.