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NCT Number: NCT04121091

Pramipexole to Target "Anhedonic Depression"

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.

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Key information

Conditions

Depression, Bipolar Anhedonia Bipolar Disorder Bipolar and Related Disorders Depression, Unipolar Depressive Disorder Dysthymia Dysthymic Disorder Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psychiatry Clinic, Lund, Region Skåne

Lund, 22358, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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. -

Treatment and study plan

Pramipexole Pill

Drug

Add-on pramipexole

Primary outcomes

  1. Dimensional Anhedonia Rating Scale (DARS) Score

    Time frame: baseline to week 10

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

Secondary outcomes

  1. Response

    Time frame: baseline to week 10

    Montgomery Åsberg Depression Rating Scale (MADRS). The range is 0-60, lower score indicating less general depressive symptoms.

    Response definition: reduction of at least 50% Remission definition: MADRS total score equal to or below 10

  2. Montgomery Åsberg Depression Rating Scale (MADRS) Score

    Time frame: baseline to week 10

    Change in depression symptoms (total score on the MADRS). The range is 0-60, lower score indicating less general depressive symptoms.

  3. Snaith-Hamilton Anhedonia Pleasure Scale

    Time frame: baseline to week 10

    Change in anhedonia symptoms (total score on the Snaith-Hamilton Anhedonia Pleasure Scale) score 0-1-2-3. Range 0-32. Higher score indicating more intense anhedonic symptoms.

  4. Generalized Anxiety Disorder-7

    Time frame: baseline to week 10

    Change in anxiety symptoms (total score on the the Generalized Anxiety Disorder-7 scale = GAD-7). Range 0-21. Higher score indicating more anxiety.

  5. Insomnia Severity Index

    Time frame: baseline to week 10

    Change in insomnia symptoms (total score on the the Insomnia Severity Index scale = ISI). Range 0-28. Higher score indicating more insomnia symptoms.

  6. Fatigue Severity Scale

    Time frame: baseline to week 10

    Change in fatigue symptoms (total score on the the Fatigue Severity scale = FSS). Range 9-63. Higher score indicating more fatigue.

  7. The Apathy Evaluation Scale

    Time frame: baseline to week 10

    Change in apathy symptoms (total score on the the The Apathy Evaluation Scale = AES). Range 0-54. Higher score indicating more severe apathy.

  8. Change in Inflammatory Biomarkers

    Time frame: baseline to week 10

    The investigators will measure blood levels of Interleukin-6 (IL-6), C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF), and White Blood Cell count (WBC) at baseline and at study completion. The investigators will test if baseline levels and treatment-associated change in inflammatory markers can predict treatment response

  9. Participation in fMRI With MID-task

    Time frame: baseline to week 10 (and baseline data as potential predictor)

    fMRI = functional magnetic resonance tomography. Structural imaging, followed by resting-state functional imaging, diffusion tensor imaging and thereafter the MID (monetary incentive delay) task.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study

Acronym: PILOT-PRAXOL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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