Overview

Pramipexole to Target "Anhedonic Depression"

Status:
Completed
Trial end date:
2021-03-18
Target enrollment:
0
Participant gender:
All
Summary
The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Region Skane
Collaborator:
Lund University
Treatments:
Pramipexole
Criteria
Inclusion Criteria:

1. Age ≥18 and ≤75.

2. Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia.

3. Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression
Rating Scale (MADRS).

4. Symptoms of anhedonia; Total-score < 27, measured by Dimensional Anhedonia Rating
Scale (DARS).

5. Ongoing treatment with at least one antidepressant drug ≥ 4 weeks without major
changes in dosage. Patients with bipolar disorder must have a mood-stabilizing drug
treatment.

6. Must sign an informed consent. -

Exclusion Criteria:

1. Ongoing pregnancy, breastfeeding or planning for pregnancy.

2. High suicidality assessed by the researcher with medical degree.

3. Ongoing substance use disorder (last 12 month).

4. Diagnosis of psychosis.

5. Ongoing involuntary psychiatric treatment.

6. History of Impulse-control disorder or current ADHD diagnosis.

7. Diagnosis of Intellectual disability, dementia, or other circumstances leading to
difficulties to understand the implications of participating in the study and to give
informed consent.

8. Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2 ) or severe cardiovascular
disease (defined as symptoms of heart failure NYHA class 2).

9. Recently committed to psychotherapy (during the last 6 weeks) or planning for
psychotherapy during the participation of the study.

10. Ongoing ECT-treatment.

11. Other diseases, disorders or medical treatments that according to the researchers
might influence the results of the study or increases the risks of the study. Such as
Parkinson's disorder, liver failure, cancer not in remission (for at least over a
year).

12. Confirmed or suspected allergy to the active substance or excipients of the drug used
in this study.

13. Committed to other trials

14. Other reasons that according to the researcher might prevent the subject to fulfill
the obligations of the study. For example insufficient drug compliance. -