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Pramipexole to Target "Anhedonic Depression" (PILOT-PRAXOL)

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ClinicalTrials.gov Identifier: NCT04121091
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Daniel Lindqvist, Region Skane

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.

Condition or disease Intervention/treatment Phase
Depression, Bipolar Depression, Unipolar Dysthymia Anhedonia Drug: Pramipexole Pill Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pramipexole Drug: Pramipexole Pill
Add-on pramipexole




Primary Outcome Measures :
  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 Outcome Measures :
  1. Response/remission [ Time Frame: baseline to week 10 ]
    Montgomery Åsberg Depression Rating Scale (MADRS) reduction 50%, MADRS ≤ 10 respectively

  2. Montgomery Åsberg Depression Rating Scale (MADRS) score [ Time Frame: baseline to week 10 ]
    Change in depression symptoms (total score on the MADRS)

  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)

  4. the Motivation and Pleasure Scale [ Time Frame: baseline to week 10 ]
    Change in motivation/anhedonia symptoms (total score on the the Motivation and Pleasure Scale)

  5. Generalized Anxiety Disorder-7 [ Time Frame: baseline to week 10 ]
    Change in anxiety symptoms (total score on the the Generalized Anxiety Disorder-7 scale)

  6. Insomnia Severity Index [ Time Frame: baseline to week 10 ]
    Change in insomnia symptoms (total score on the the Insomnia Severity Index scale)

  7. Fatigue Severity Scale [ Time Frame: baseline to week 10 ]
    Change in fatigue symptoms (total score on the the Fatigue Severity scale)

  8. The Apathy Evaluation Scale [ Time Frame: baseline to week 10 ]
    Change in apathy symptoms (total score on the the The Apathy Evaluation Scale)

  9. Change in inflammatory biomarkers [ Time Frame: baseline to week 10 ]
    The investigators will measure blood levels of Interleukin-6, C-reactive protein, Tumor Necrosis Factor Alpha, and White Blood Cell count at baseline and at study completion. The investigators will test if baseline levels and treatment-associated change in inflammatory markers can predict treatment response

  10. Change in brain imaging parameters [ Time Frame: baseline to week 10 (and baseline data as potential predictor) ]
    Structural imaging, followed by resting-state functional imaging, diffusion tensor imaging and thereafter the monetary incentive delay task



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121091


Contacts
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Contact: Daniel Lindqvist, MD, PhD +4646173885 daniel.lindqvist@med.lu.se

Locations
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Sweden
Psychiatry Clinic, Lund, Region Skåne Recruiting
Lund, Sweden, 22358
Contact: Daniel Lindqvist       daniel.lindqvist@med.lu.se   
Sponsors and Collaborators
Region Skane
Lund University

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Responsible Party: Daniel Lindqvist, Principal Investigator, Region Skane
ClinicalTrials.gov Identifier: NCT04121091     History of Changes
Other Study ID Numbers: 2019-001907-19
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anhedonia
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bipolar and Related Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents