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B-HAPPINCT07664852

Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Start date: Sep 1, 2026 to Oct 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 10 of 13 entries
    • Site details revised
  2. Interventions: Pramipexole (Drug) to Placebo (Drug), Pramipexole (Drug)
    • Secondary endpoints: 9 to 13
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline
Timeframe: Between baseline visit and week 6

Secondary (13)

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 and week 21
Change in sedentary behaviour (SED) between baseline, week 6 and week 21
Change in light physical activity (LPA) between baseline, week 6 and week 21
Change in moderate- to vigorous physical activity (MVPA) between baseline, week 6 and week 21
Change in Dimensional Anhedonia Rating Scale (DARS) from baseline to week 6 and 21
Show 8 moreShow less
Change in Apathy Evaluation Scale (AES) from baseline to week 6 and 21
Change in Clinical Global Impression - Severity (CGI-S) between baseline, week 6 and 21
Change in EuroQol - Five dimensions - Five levels (EQ-5D-5L) between baseline, week 6 and 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Young Mania Rating Scale (YMRS)
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Modified Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (M-QUIP-RS)
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Modified Problem Gambling Severity Index (M-PGSI)
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Alcohol Use Disorders Identification Test (AUDIT)
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Drug Use Disorders Identification Test (DUDIT)

Arms and interventions

Pramipexole-treatedExperimental

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

Placebo-treatedPlacebo comparator

6 weeks of treatment with placebo adjunctive to a mood stabilizer.

Drugs: Pramipexole, Placebo

Sites

1 site in 1 country

  • Adult PsychiatryLund, Skåne County, Sweden