Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Pramipexole for Bipolar Disorder (BD)

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.

Official registry: https://clinicaltrials.gov/study/NCT07664852 · Daniel Lindqvist · enrollment listed as 126

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pramipexole, or Placebo. The registry lists allocation as randomized. Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates.

They plan to enroll about 126 people at Lund. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

B-HAPPI: Bipolar Disorder and High-dose Adjunctive Pramipexole in Anhedonic Depression - a Phase III, Double-blind, Randomized Controlled Trial

Interventions: Pramipexole, Placebo

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

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • The participant has given their written consent to participate in the trial
  • 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

Public study contact (from the registry)

Mirjam Wolfschlag, PhD

+46724596431

mirjam_katharina.wolfschlag@med.lu.se

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07664852 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07664852?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07664852?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary