Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
ConditionBipolar Disorder (BD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDaniel Lindqvist
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Pramipexole
- Placebo
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Daniel Lindqvist
Lead sponsor
Region Skane
Sponsor institution
Source ClinicalTrials.gov