Phase
Condition
Depression
Treatment
Pramipexole
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Previous participation in RCT testing the short-term efficacy of pramipexole vsplacebo (EudraCT# 2022-001563-26).
Study participants randomized to pramipexole in the RCT who wish to continue withtheir treatment can enrol in the study.
Study participants randomized to placebo in the RCT who continue to fulfil theinclusion criteria (and none of the exclusion criteria) after the RCT can enrol inthe 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 "clinicallysignificant anhedonia".
Exclusion
Exclusion Criteria:
Pregnancy, breastfeeding or planned pregnancy (if female).
High suicide risk according to the overall clinical assessment of the researchphysician.
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 acurrent ADHD diagnosis with hyperactivity.
Diagnosis of intellectual disability, dementia, or other circumstance that makes itdifficult to understand the meaning of participating in the trial and give informedconsent.
Diagnosis of renal failure or severe cardiovascular disease (specificallysymptomatic heart failure NYHA Class II). Blood samples from RCT are sufficient torule this out.
Recently started psychotherapy (within 6 weeks) or planning to start such treatmentduring participation in the trial.
Ongoing ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a periodexceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to preventthe onset of a new episode).
Other medical conditions or other concomitant drug treatment (see section 14.5)which, in the opinion of the investigators, may affect the evaluability of the trialor conditions that increase trial risk. For example, Parkinson's disease, hepaticinsufficiency, ongoing cancer not in remission for more than one year, gastricbypass surgery that affects the absorption of extended release tablets.
Known or suspected allergy to any active substance or excipient in the medicinalproduct included in the trial.
Participation in other treatment studies.
Other reason, as assessed by the investigator, that prevents the research subject'sparticipation, such as the risk that the research subject is unable to complete thetrial (non-compliance).
Study Design
Study Description
Connect with a study center
Region Skåne
Lund, Scania 221 85
SwedenActive - Recruiting
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