Drug treatment with Pramipexole for lack of interest and motivation in depression.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Age =18 years =75 years.
2. Diagnosis of: unipolar depressive episode or bipolar disorder in depressive phase, or dysthymia.
3. 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.
4. 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).
5. The research subject has given informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Pregnancy, breastfeeding or planned pregnancy (if female).
2. High suicide risk according to the overall clinical assessment of the research physician.
3. Ongoing substance abuse (within 6 months).
4. Diagnosis of current psychosis.
5. Known diagnosis of Emotionally Unstable Personality Disorder.
6. Treatment under LPT.
7. History of, or strong clinical suspicion, impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
8. 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.
9. Diagnosis of renal failure (eGFR < 50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).
10. Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
11. 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 period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
12. Other medical conditions, and other medical procedures, or other concomitant drug treatment (see section 14.5) 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 known influence on absorption of extended-release tablets in the gastrointestinal tract.
13. Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
14. Participation in other treatment studies.
15. 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).