Status:
COMPLETED
Pramipexole to Target "Anhedonic Depression"
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
Conditions:
Depression, Bipolar
Depression, Unipolar
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤75.
- Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia.
- Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression Rating Scale (MADRS).
- Symptoms of anhedonia; Total-score \< 27, measured by Dimensional Anhedonia Rating Scale (DARS).
- 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.
- Must sign an informed consent. -
Exclusion
- Ongoing pregnancy, breastfeeding or planning for pregnancy.
- High suicidality assessed by the researcher with medical degree.
- Ongoing substance use disorder (last 12 month).
- Diagnosis of psychosis.
- Ongoing involuntary psychiatric treatment.
- History of Impulse-control disorder or current ADHD diagnosis.
- 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.
- Diagnosis of renal failure (eGFR \< 50 ml/min/1,73 m2 ) or severe cardiovascular disease (defined as symptoms of heart failure NYHA class 2).
- Recently committed to psychotherapy (during the last 6 weeks) or planning for psychotherapy during the participation of the study.
- Ongoing ECT-treatment.
- 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).
- Confirmed or suspected allergy to the active substance or excipients of the drug used in this study.
- Committed to other trials
- Other reasons that according to the researcher might prevent the subject to fulfill the obligations of the study. For example insufficient drug compliance. -
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04121091
Start Date
October 4 2019
End Date
March 18 2021
Last Update
December 12 2025
Active Locations (1)
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1
Psychiatry Clinic, Lund, Region Skåne
Lund, Sweden, 22358