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Depression, BipolarPhase 2PILOT-PRAXOLNCT04121091

Pramipexole to Target "Anhedonic Depression"

A Phase 2 study testing Pramipexole Pill in people with Depression, Bipolar and Depression, Unipolar, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pramipexole Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSweden
Study dates
4 Oct 2019to 18 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. -

Who cannot join

  • 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.
Show all 14Show fewer
  • 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. -

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Psychiatry Clinic, Lund, Region Skåne

    Lund, 22358

Other trials in Sweden

About this study

Official title: Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study

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.

Being tested
Pramipexole Pill
Medical subject headings
Bipolar Disorder, Depressive Disorder, Dysthymic Disorder, Anhedonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pramipexole PillDrug

    Add-on pramipexole

Study groups in NCT04121091
Study groupRoleWhat they receive
PramipexoleExperimentalNot described
Receives: Drug: Pramipexole Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline to week 10

Secondary outcomes (9)

  1. Response

    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

    Measured: baseline to week 10

  2. Montgomery Åsberg Depression Rating Scale (MADRS) Score

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

    Measured: baseline to week 10

  3. Snaith-Hamilton Anhedonia Pleasure Scale

    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.

    Measured: baseline to week 10

  4. Generalized Anxiety Disorder-7

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

    Measured: baseline to week 10

  5. Insomnia Severity Index

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

    Measured: baseline to week 10

  6. Fatigue Severity Scale

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

    Measured: baseline to week 10

  7. The Apathy Evaluation Scale

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

    Measured: baseline to week 10

  8. Change in Inflammatory Biomarkers

    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

    Measured: baseline to week 10

  9. Participation in fMRI With MID-task

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start4 Oct 2019
  3. Primary completion18 Mar 2021
  4. Study completion18 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04121091
Sponsor's protocol ID
2019-001907-19
Other IDs
2019
Acronym
PILOT-PRAXOL
Status last verified
Apr 2025
First submitted
4 Oct 2019
Last updated
12 Dec 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pramipexole Pill in people with Depression, Bipolar and Depression, Unipolar, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dimensional Anhedonia Rating Scale (DARS) Score (time frame: baseline to week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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