Adjuvant treatment with Pramipexole for anhedonia symptoms in depression - PRIME-PRAXOL

Prior treatment

• 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.

Other illness

• Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
• Known diagnosis of Emotionally Unstable Personality Disorder.
• 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.

Lab values

• Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).

Other

• 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).
• 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.
• Treatment under LPT.

• 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.