Trials / Completed
CompletedNCT04121091
Pramipexole to Target "Anhedonic Depression"
Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Region Skane · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pramipexole Pill | Add-on pramipexole |
Timeline
- Start date
- 2019-10-04
- Primary completion
- 2021-03-18
- Completion
- 2021-03-18
- First posted
- 2019-10-09
- Last updated
- 2025-12-12
- Results posted
- 2025-12-12
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT04121091. Inclusion in this directory is not an endorsement.