Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression

Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes. * Population: 126 patients with bipolar depression * Intervention: Pramipexole added to ongoing treatment with mood stabilizer, flexible dosing - target dose 2.1 mg/day * Control: Add-on identical placebo * Outcomes: Primary outcome is change in anhedonia symptoms between baseline and 6 weeks of intervention. Key secondary outcomes include (for example) general depression symptoms and safety measures. There will be a 15 weeks open label follow up. If shown to be effective and safe, this intervention could become a key treatment option for bipolar depression, reducing suffering and potentially lowering suicide risk.

NCT Number	NCT07664852
Lead Sponsor	Daniel Lindqvist
Conditions	Bipolar Disorder (BD)
Enrollment	126 participants
Start Date	2026-09-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-01