Pramipexole to Target "Anhedonic Depression"

NCT04121091 | Completed Phase 2 Results

• 1 other identifier: 2019-001907-19
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anhedonia; Depression, Bipolar; Depression, Unipolar; Dysthymia

Outcome Measures

Primary Outcomes (1)

• Dimensional Anhedonia Rating Scale (DARS) Score

  Change in anhedonia symptoms (total score on the DARS). The range is 0-68, lower score indicating more severe anhedonia.

  baseline to week 10

Secondary Outcomes (9)

• Response

  baseline to week 10

• Montgomery Åsberg Depression Rating Scale (MADRS) Score

  baseline to week 10

• Snaith-Hamilton Anhedonia Pleasure Scale

  baseline to week 10

• Generalized Anxiety Disorder-7

  baseline to week 10

• Insomnia Severity Index

  baseline to week 10

Study Arms (1)

Pramipexole

EXPERIMENTAL

Drug: Pramipexole Pill

Interventions

Pramipexole Pill DRUG

Add-on pramipexole

Pramipexole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Psychiatry Clinic, Lund, Region Skåne

Lund, 22358, Sweden

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder; Dysthymic Disorder; Anhedonia

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Inherent limitations and caveats of this test-of-feasibility study: small-scale (small sample) and open-label design.

Results Point of Contact

• Title: Dr Daniel Lindqvist
• Organization: Unit of Biological and Precision Psychiatry

daniel.lindqvist@med.lu.se

+4646173885

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: October 4, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)