Long-term Efficacy of Pramipexole in Anhedonic Depression (NCT05825235) | Clinical Trial Compass
CompletedPhase 3
Long-term Efficacy of Pramipexole in Anhedonic Depression
Sweden55 participantsStarted 2023-04-21
Plain-language summary
The purpose of the study is to assess the long-term efficacy and safety of add-on pramipexole for treatment of patients with anhedonic depression.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Previous participation in RCT testing the short-term efficacy of pramipexole vs placebo (EudraCT# 2022-001563-26).
* Study participants randomized to pramipexole in the RCT who wish to continue with their treatment can enrol in the study.
* Study participants randomized to placebo in the RCT who continue to fulfil the inclusion criteria (and none of the exclusion criteria) after the RCT can enrol in the study.
* The research subject has given informed consent to participate in the study.
Additional inclusion criterion for patients receiving placebo during the RCT
* Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C). This has been adopted in previous studies as a definition of "clinically significant anhedonia".
Exclusion Criteria:
* Pregnancy, breastfeeding or planned pregnancy (if female).
* High suicide risk according to the overall clinical assessment of the research physician.
* Ongoing substance abuse (within 6 months).
* Diagnosis of current psychosis.
* Known diagnosis of Emotionally Unstable Personality Disorder.
* Treatment under LPT.
* History of impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
* Diagnosis of intellectual disability, dementia, or other circumstance that makes it difficult to understand the meaning of participating in the trial and give informed consent.
* Diagnosis of renal failure or severe cardiovascular disease …