drugset / Trial / NCT05825235
Long-term Efficacy of Pramipexole in Anhedonic Depression
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to assess the long-term efficacy and safety of add-on pramipexole for treatment of patients with anhedonic depression.
Timeline
- Start
- 2023-04-21
- Primary completion
- 2025-12-05
- Completion
- 2025-12-05
Outcome
Met primary endpoint
paper The primary outcome was met: pramipexole was associated with a greater reduction in SHAPS scores compared to placebo PMID 42286321 ↗
paper mean difference: -4.04, 95% confidence interval: -6.89 to -1.18, P = 0.006 PMID 42286321 ↗
Publications
- Ventorp F, Asp M, Olsson S, Lindahl J, Moller S, Svensson M, Angeby F, Pravdinske A, Tjernberg J, Schrey S, Stahl D, Magnusson V, Eliasson E, Agelii-Weber A, Stalhammar E, van Westen D, Deierborg T, Mansson KNT, Pizzagalli DA, Hammar A, Tornberg AB, Bjorkstrand J, Lindqvist D. Efficacy and target engagement of dopamine agonist pramipexole for anhedonic depression: a randomized placebo-controlled trial. Nat Med. 2026 Jun 12. doi: 10.1038/s41591-026-04465-9. Online ahead of print.
- Lindahl J, Asp M, Stahl D, Tjernberg J, Eklund M, Bjorkstrand J, van Westen D, Jensen J, Mansson K, Tornberg A, Svensson M, Deierborg T, Ventorp F, Lindqvist D. Add-on pramipexole for anhedonic depression: study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden. BMJ Open. 2023 Nov 30;13(11):e076900. doi: 10.1136/bmjopen-2023-076900.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 0.26 mg | Oral |
| Subject | Pramipexole | Unknown | 3.15 mg | Oral |