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Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression

NCT07664852 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Bipolar Disorder (BD)

Interventions

DRUG

Pramipexole

6 weeks of treatment with the dopamine agonist pramipexole adjunctive to a mood stabilizer. Target dose 2.1 mg base/day.

DRUG

Placebo

6 weeks of treatment with a placebo for the dopamine agonist pramipexole adjunctive to a mood stabilizer.

Sponsors & Collaborators

  • Daniel Lindqvist

    lead OTHER

Principal Investigators

  • Daniel Lindqvist, PhD, MD · Region Skåne, Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664852 on ClinicalTrials.gov