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OPTIMUM-Neuro RCT
NCT05531591Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2019
- Primary completion
- Jul 2024
- Countries
- 2
- Modality
- DNA Intercalators/Alkylators
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 4, randomised, single-blind trial of aripiprazole, bupropion, lithium and nortriptyline in major depressive disorder (MDD) (5 arms), sponsored by Center for Addiction and Mental Health. Primary endpoints: Change in Psychological Well-Being at 20 weeks, Change in the Number of Participants With Remission From Depression at 20 weeks and 2 more. Started Aug 2019; status: completed.
02
Design
5 arms- Study design
- RandomizedSingle-blind
Aripiprazole Augmentation
Augment current antidepressant with aripiprazole.
Bupropion Augmentation
Augment current antidepressant with bupropion.
Switch to Bupropion
Switch from current antidepressant to bupropion.
Lithium Augmentation
Augment current antidepressant with lithium.
Switch to Nortriptyline
Switch from current antidepressant to nortriptyline.
03
Who it enrols
Older adults (60+) with current Major Depressive Disorder (MDD) who have failed to respond to two or more antidepressant trials. Excludes patients with dementia, bipolar disorder, schizophrenia, high suicide risk, or unstable medical illness.
04
Endpoints
Primary
Change in Psychological Well-Being
Change in the Number of Participants With Remission From Depression
Safety Outcomes Assessment for Serious Adverse Events
Cognitive Decline in Executive and Episodic Memory
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