Depression MedDRA version: 20.0 Level: PT Classification code 10002511 Term: Anhedonia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Pramipexole Orion
Product Name: Pramipexole Orion 0,26 mg, 0,52 mg, 1,05 mg and 2,1 mg
Pharmaceutical Form: Prolonged-release tablet
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion 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-A°sberg Depression Rating Scale (MADRS). 4. Symptoms of anhedonia; Total-score =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Every second week between from baseline to week 10;Main Objective: The main objective is to test the efficacy of add-on pramipexole in treating anhedonia in patients with depression. ;Primary end point(s): Absolute change in score on the Dimensional Anhedonia Rating Scale (DARS); Secondary Objective: Secondary objectives are: 1. To investigate optimal dosing of pramipexole in order to treat anhedonia and at the same time avoid side effects 2. To test the efficacy of pramipexole to treat symptoms of fatigue, anxiety, sleep problems, and general depressive symptoms 3. To investigate an fMRI-paradigm testing the reward system (monetary incentive task) and inflammatory blood markers as predictors of pramipexole treatment response | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Absolute change in score on the Montgomery-Åsberg Rating Scale (MADRS), the Snaith–Hamilton Pleasure Scale (SHAPS), the Motivation and Pleasure Scale (MAP-SR), the General Anxiety Disorder-7 (GAD-7), the Fatigue Severity Scale (FSS), the Insomnia Severity Index (ISI), and the Apathy Evaluation Scale (AES). 2. Change in inflammatory markers over the treatment course 3. Optimal dosing interval and number of drop-outs 4. Change in fMRI BOLD-signal in the ventral striatum during the monetary incentive delay task pre/post pramipexole treatment ;Timepoint(s) of evaluation of this end point: Every second week between from baseline to week 10 except blood inflammatory markera and fMRI (two time points - baseline and at week 10 when study is completed) | — |
Countries
Sweden
Contacts
Public ContactVuxenpsykiatri Lund
Region Skåne
Outcome results
None listed