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NCT05531591 · ClinicalTrials.gov registry record · Phase 4
RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT)
A Phase 4 study, sponsored by Centre for Addiction and Mental Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 87
- Enrollment target
NCT05531591: Completed Phase 4 study, sponsored by Centre for Addiction and Mental Health.
NCT05531591 is a Phase 4 study that has completed, run by Centre for Addiction and Mental Health. The registered enrollment target is 87 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05531591, a Phase 4 study, has completed, sponsored by Centre for Addiction and Mental Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 87 participants
- Enrollment target
Study Summary
The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.
Primary Outcome
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, Standard Deviation (SD)=10.
Interventions
- DRUG Aripiprazole Augmentation
- DRUG Bupropion Augmentation
- DRUG Switch to bupropion
- DRUG Lithium Augmentation
- DRUG Switch to nortriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 4 |
What the finished NCT05531591 record still lists
NCT05531591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Aripiprazole Augmentation is the first listed.
NCT05531591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05531591 about?
NCT05531591 is a clinical study titled "RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT)". The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.
What is the current status of trial NCT05531591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 87 participants. The study started on 2019-08-01. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT05531591?
The interventions under investigation include: Aripiprazole Augmentation (DRUG), Bupropion Augmentation (DRUG), Switch to bupropion (DRUG), Lithium Augmentation (DRUG), Switch to nortriptyline (DRUG).
Who is sponsoring clinical trial NCT05531591?
This trial is sponsored by Centre for Addiction and Mental Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05531591's enrollment target sits among peer trials
87 923rd of 2000 higher than 1,075 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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