Adjuvant treatment with Pramipexole for anhedonia symptoms in depression - PRIME-PRAXO
- Conditions
- Major depressionTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]MedDRA version: 20.0Level: PTClassification code: 10002511Term: Anhedonia Class: 100000004873
- Registration Number
- CTIS2024-512495-35-00
- Lead Sponsor
- Region Skane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Age =18 years =75 years., Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia., Anhedonia symptoms: 3 or 4 points on = 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C)., Ongoing treatment with at least one antidepressant or mood stabilizing medication = 4 weeks., Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression)., The research subject has given informed consent to participate in the study.
Pregnancy, breastfeeding or planned pregnancy (if female)., Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial., Ongoing or planned ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode)., Other medical conditions or other concomitant drug treatment which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, bariatric surgery with a known impact on absorption of extended-release tablets., Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial., Participation in other treatment studies., Other reason, as assessed by the investigator, that prevents the research subject's participation, such as the risk that the research subject is unable to complete the trial (non-compliance)., 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 or a strong clinical suspicion of impulse control disorder (including current bingeeating 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 (eGFR < 50 ml/min/1,73 m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method