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Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)
NCT04493320Phase 4
Key facts
- Status
- Terminated
- Start
- Feb 2021
- Primary completion
- Oct 2021
- Countries
- 1
- Sponsor
- New York State Psychiatric Institute
- Modality
- Small Molecules
- Drugs
- levodopa
- Conditions
- major depressive disorder (MDD)persistent depressive disorder (PDD)cognitive impairment
01
Overview
Phase 4, randomised, double-blind trial of levodopa in major depressive disorder (MDD), persistent depressive disorder (PDD) and cognitive impairment (2 arms), sponsored by New York State Psychiatric Institute. Primary endpoints: Effort Expenditure for Rewards Task at 3 weeks, Digit Symbol Test at 7 weeks and 4 more. Started Feb 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
L-DOPA, Then Placebo
3 weeks of L-DOPA followed by 1 week taper, then 3 weeks of placebo followed by 1 week taper.
Placebo, Then L-DOPA
3 weeks of placebo followed by 1 week taper, then 3 weeks of L-DOPA followed by 1 week taper.
03
Who it enrols
Adults aged 60 or older with Major Depressive Disorder or Persistent Depressive Disorder and slowed processing or gait speed, or healthy elders.
04
Endpoints
Primary
Effort Expenditure for Rewards Task
Digit Symbol Test
Pattern Comparison Test
Letter Comparison Test
Single Task Gait Speed Test
Secondary
Montgomery Asberg Depression Rating Scale
Quick Inventory for Depressive Symptomatology
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