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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pramipexole

    Drug

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

  • Placebo

    Drug

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Pramipexole-treatedExperimental treatment 1 intervention
Group B: Placebo-treatedPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline

14 items rated from points with 1 to 4. Higher scores equal more severe anhedonia. Score range: 14-56.

Time frame
Between baseline visit and week 6

Secondary outcomes

1

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 and week 21

10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression. Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.

Time frame
Between baseline visit and week 21
2

Change in sedentary behaviour (SED) between baseline, week 6 and week 21

Parameter is part of determining physical activity measured by wearable activity meters

Time frame
Between baseline and week 21
3

Change in light physical activity (LPA) between baseline, week 6 and week 21

Parameter is part of determining physical activity measured by wearable activity meters

Time frame
Between baseline and week 21
4

Change in moderate- to vigorous physical activity (MVPA) between baseline, week 6 and week 21

Parameter is part of determining physical activity measured by wearable activity meters

Time frame
Between baseline and week 21

Other outcomes

1

Clinical improvement per structured clinical assessments

e.g. Association for Methodology and Documentation in Psychiatry

Time frame
Between baseline visit and week 21
2

Digital neuropsychological test battery

Trail Making Test, Rey Auditory Verbal Learning Test, Click Reaction Time, Victoria Stroop Test, Digital Corsi Block-Tapping Test, Symbol Digit Processing Test, and the Verbal Fluency Test

Time frame
Between baseline visit and week 21
3

Changes in Blood-oxygen-level dependent imaging (BOLD) activity

In the nucleus accumbens during fMRI with the Monetary Incentive Delay (MID) task between baseline and week 6

Time frame
Between baseline and week 6
4

Relevant blood, CSF, and fMRI biomarkers

Genetic variants linked to dopamine, inflammation, cellular health (incl. neurodegeneration and biomarkers of brain injury), cellular stress and metabolism, growth factors and monoamine turnover (and its receptors), the blood-brain barrier and its drug transporters, and the concentration of the investigational drug. Biomarker assays will be prioritised based on scientific relevance and available funding.

Time frame
Between baseline and week 21

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel Lindqvist

Lead sponsor

Region Skane

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: