Pramipexole adds on to mood stabilizers for bipolar depression
Official title: B-HAPPI: Bipolar Disorder and High-dose Adjunctive Pramipexole in Anhedonic Depression - a Phase III, Double-blind, Randomized Controlled Trial
Run by Region Skane · NCT07664852 · Data updated 2026-11-12
This trial tests whether adding pramipexole to standard mood-stabilizing treatment helps reduce anhedonia in adults with bipolar depression compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund, Skåne County) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07664852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with bipolar I or II disorder in a depressive state and significant anhedonia despite mood-stabilizer therapy.
✕Probably not a fit
Patients without persistent anhedonia, those not on mood stabilizers, or individuals with contraindications to pramipexole may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 3 randomized, placebo-controlled trial evaluating pramipexole as an add-on therapy for adults with bipolar I or II depression. Participants will continue their mood-stabilizing medications while receiving flexible-dose pramipexole or matched placebo for six weeks, with the primary outcome focusing on changes in anhedonia. Secondary outcomes include broader depressive symptoms and safety. After the double-blind period, there is a 15-week open-label follow-up to monitor longer-term effects and tolerability.
Why it matters
Potential benefit: If successful, pramipexole could reduce anhedonia and depressive symptoms in bipolar disorder when added to existing treatment.
How similar studies have gone: Prior small studies in bipolar depression suggested potential benefit of pramipexole, but larger confirmatory data are needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participant has given their written consent to participate in the trial. * For WOCBP, adequate contraception should be used (see section 9.6) and a negative pregnancy test is (u-hCG) required. WOCBP: For the purpose of this protocol, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Age ≥18 years ≤80 years. * Diagnosis of bipolar disorder type I or II as verified by ICD-11. * Ongoing depressive state according to ICD-11 (at least 2 weeks, maximum 18 months). * Significant anhedonia, defined as 3 or 4 points on ≥3 items on the SHAPS self-rating scale * Minimum score on the MADRS expert rating scale ≥ 20 * Ongoing treatment with at least one mood stabilising agent (with sufficient antimanic protection as determined by clinical judgment). If treatment with lithium is ongoing, serum levels must be within the reference range of 0.4-0.9. The latest concentration measurement should be within one month before treatment initiation. If treatment is ongoing with a mood stabilising anticonvulsant or an antipsychotic, any dose adjustments made within 4 weeks prior to study start must be reported. Mood-stabilising anticonvulsants and antipsychotics must not be newly initiated within 4 weeks prior to study start. If treatment with antidepressants is ongoing the dose must have been stable for at least 4 weeks. Exclusion Criteria: * Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification. * Meets criteria for a mixed episode according to ICD-11. * High suicide risk according to the overall clinical assessment of the research physician. * Ongoing substance abuse (within 6 months). * Ongoing psychotic symptoms. * Prior diagnosis of schizophrenia or schizoaffective disorder. * Clinical presentation is primarily attributable to a personality disorder. * Subject to compulsory psychiatric care (LPT). * History of, or strong clinical suspicion of, impulse control disorder (including current binge-eating disorder). A diagnosis of ADHD is not, in itself, an exclusion criterion; however, participants will be excluded if the clinical presentation is primarily characterised by impulse control-related symptoms. * Diagnosis of intellectual disability, dementia, cognitive impairment, or other conditions (including those related to the depressive disorder itself) that, in the judgment of the study physician, may substantially impair the participant's ability to understand the study and provide informed consent. * Diagnosis of renal failure (eGFR \<50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure \>Class II New York Heart Association (NYHA)). * Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial. Psychoeducational treatment, which is standard care at bipolar units, is not an exclusion criterion. * Ongoing treatment with ECT, ketamine or rTMS. * Other medical conditions, other ongoing interventions or other concomitant drug treatment (see section 7.3) that, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example: Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year. * Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial. * Participation in other treatment studies. * Other reason, as assessed by the investigator, that prevents the research participant's participation, such as the risk that the research participant is unable to complete the trial (non-compliance).
Where it's running
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Adult Psychiatry
Lund, Skåne County, Sweden Recruiting
Study contacts
- Principal investigator: Daniel Lindqvist, PhD, MD — Region Skåne, Lund University
- Study coordinator: Mirjam Wolfschlag, PhD
- Email: mirjam_katharina.wolfschlag@med.lu.se
- Phone: +46724596431
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.