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AnhedoniaPhase 3LONG-PRAXOLNCT05825235

Long-term Efficacy of Pramipexole in Anhedonic Depression

A Phase 3 study testing Pramipexole in people with Anhedonia and Depression, 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 purpose of the study is to assess the long-term efficacy and safety of add-on pramipexole for treatment of patients with anhedonic depression. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anhedonia, Depression
What is being tested?
Pramipexole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteSweden
Study dates
21 Apr 2023to 5 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Previous participation in RCT testing the short-term efficacy of pramipexole vs placebo (EudraCT# 2022-001563-26).
  • Study participants randomized to pramipexole in the RCT who wish to continue with their treatment can enrol in the study.
  • Study participants randomized to placebo in the RCT who continue to fulfil the inclusion criteria (and none of the exclusion criteria) after the RCT can enrol in the study.
  • The research subject has given informed consent to participate in the study.
  • Additional inclusion criterion for patients receiving placebo during the RCT
  • Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C). This has been adopted in previous studies as a definition of "clinically significant anhedonia".

Who cannot join

  • Pregnancy, breastfeeding or planned pregnancy (if female).
  • High suicide risk according to the overall clinical assessment of the research physician.
  • Ongoing substance abuse (within 6 months).
  • Diagnosis of current psychosis.
  • Known diagnosis of Emotionally Unstable Personality Disorder.
  • Treatment under LPT.
Show all 15Show fewer
  • History of impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
  • Diagnosis of intellectual disability, dementia, or other circumstance that makes it difficult to understand the meaning of participating in the trial and give informed consent.
  • Diagnosis of renal failure or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II). Blood samples from RCT are sufficient to rule this out.
  • Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
  • Ongoing ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
  • Other medical conditions or other concomitant drug treatment (see section 14.5) which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, gastric bypass surgery that affects the absorption of extended release tablets.
  • Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
  • Participation in other treatment studies.
  • Other reason, as assessed by the investigator, that prevents the research subject's participation, such as the risk that the research subject is unable to complete the trial (non-compliance).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Region Skåne

    Lund, Skåne County, 221 85

Other trials in Sweden

About this study

Official title: Long-term Efficacy and Tolerability of add-on Pramipexole for Anhedonic Depression - an Open Label Follow-up Study

The purpose of the study is to assess the long-term efficacy and safety of add-on pramipexole for treatment of patients with anhedonic depression.

Read the detailed description

The heterogeneity of depression suggests that several 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 a promising endophenotype within the depression spectrum, with a distinct pathophysiology involving 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.

The aim of this open label follow-up study is to test the long-term efficacy and tolerability of add-on pramipexole in anhedonic depression. This is a continuation study of an RCT (EudraCT# 2022-001563-26) in which patients are randomized to either pramipexole or placebo for 9 weeks. After completion of the RCT, patients will be offered to participate in the current trial. Approximately 50% of the patients have been treated with pramipexole and 50% with placebo within the frames of the RCT. Patients randomized to pramipexole in the RCT will continue on their current dose and patients randomized to placebo will start pramipexole using the same dosing schedule as in the RCT. A total of 80 research subjects with unipolar depression, bipolar disorder in depressive phase, or dysthymia will be offered participation in the study after completing the RCT given that they fulfill all the inclusion criteria, and none of the exclusion criteria.

Subjects have study visits once a month during 6 months, or more often if needed based on side effects. Symptom severity, side effects and ecological momentary assessments are recorded at each study visit and dose titration schedule is modified as needed. Between study visits, research subjects may contact study personnel and the investigators can quickly arrange for an additional study visit if needed.

After the study, the decision to continue with pramipexole outside of the study or discontinue with pramipexole will be based on patient preference in combination with a willingness of the patient's regular physician to take over the treatment outside of the study.

Being tested
Pramipexole
Keywords
anhedonia, depression, dopamine, pramipexole
Medical subject headings
Anhedonia, Depression

What participants receive

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

  • PramipexoleDrug

    6 months of treatment with add-on Pramipexole

Study groups in NCT05825235
Study groupRoleWhat they receive
PramipexoleExperimentalPramipexole prolonged-release tablet with doses ranging from 0.26 mg base to 3.15 mg base / day, study duration 6 months
Receives: Drug: Pramipexole

What is being measured

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

  1. Anhedonia symptoms

    Total Snaith Hamilton Anhedonia Pleasure (SHAPS) self-report scale scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Baseline

  2. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 1

  3. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 2

  4. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 3

  5. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 4

  6. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 5

  7. Anhedonia symptoms

    Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

    Measured: Month 6

Secondary outcomes (64)

  1. Core depression symptoms

    Hamilton Depression Rating Scale-6 (HDRS6) scores (subscale of HDRS-17)

    Measured: baseline

  2. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 1

  3. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 2

  4. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 3

  5. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 4

  6. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 5

  7. Core depression symptoms

    HDRS6 scores (subscale of HDRS-17)

    Measured: Month 6

  8. Ecological momentary assessments

    Number of steps/day, movement pattern distribution over the day, walking distance, time spent in light, moderate and intense physical activity, resting heart rate, blood oxygen saturation, heart rate variability (stress scores), sleep latency (time to fall asleep), sleep awakening (how often you wake up during the night), wakefulness (time in minutes awake during a night), time in deep sleep, sleep efficiency (time asleep vs. total time in bed). All variables are measured using activity meters.

    Measured: baseline

  9. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 1

  10. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 2

  11. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 3

  12. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 4

  13. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 5

  14. Ecological momentary assessments

    By using activity meters, we will analyze relevant outcomes related to physical activity, sleep, and heart rate

    Measured: Month 6

  15. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: baseline

  16. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 1

  17. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 2

  18. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 3

  19. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 4

  20. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 5

  21. Anhedonic symptoms

    Dimensional Anhedonia Rating Scale (DARS) total score

    Measured: Month 6

  22. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: baseline

  23. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 1

  24. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 2

  25. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 3

  26. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 4

  27. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 5

  28. General depressive symptoms

    Montgomery-Åsberg Depression Rating Scale (MADRS-S)

    Measured: Month 6

  29. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Baseline

  30. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 1

  31. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 2

  32. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 3

  33. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 4

  34. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 5

  35. Sleep and insomnia

    Insomnia Severity Index (ISI) total score

    Measured: Month 6

  36. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Baseline

  37. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 1

  38. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 2

  39. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 3

  40. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 4

  41. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 5

  42. Apathy symptoms

    Apathy Evaluation Scale (AES) total score

    Measured: Month 6

  43. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: baseline

  44. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 1

  45. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 2

  46. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 3

  47. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 4

  48. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 5

  49. Anxiety symptoms

    Generalized Anxiety Disorder 7-item scale (GAD-7)

    Measured: Month 6

  50. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Baseline

  51. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 1

  52. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 2

  53. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 3

  54. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 4

  55. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 5

  56. Life quality

    Brunnsviken Brief Quality of life scale (BBQ) total score

    Measured: Month 6

  57. Side effects

    Number and severity of adverse events

    Measured: Baseline

  58. Side effects

    Number and severity of adverse events

    Measured: Month 1

  59. Side effects

    Number and severity of adverse events

    Measured: Month 2

  60. Side effects

    Number and severity of adverse events

    Measured: Month 3

  61. Side effects

    Number and severity of adverse events

    Measured: Month 4

  62. Side effects

    Number and severity of adverse events

    Measured: Month 5

  63. Side effects

    Number and severity of adverse events

    Measured: Month 6

  64. Cognitive symptoms

    Change in cognitive performance using the WAIS-IV, Repeatable Battery for the Assessment of Neuropsychological Status, Delis-Kaplan Executive Function System.

    Measured: 6 months

Timeline

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

  1. First posted24 Apr 2023
  2. Study start21 Apr 2023
  3. Primary completion5 Dec 2025
  4. Study completion5 Dec 2025

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Within the frame of the previous RCT study (Eudra CT 2022-001563-26) approximately 50% of the participants have been treated with the study product and 50% with placebo. In this study all participants receive the study product, so some will continue their ongoing treatment with the study product and some will start using the study product.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05825235
Sponsor's protocol ID
2022-502270-17-00
Acronym
LONG-PRAXOL
Status last verified
Apr 2026
First submitted
23 Mar 2023
Last updated
28 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ventorp F, Asp M, Olsson S, Lindahl J, Moller S, Svensson M, Angeby F, Pravdinske A, Tjernberg J, Schrey S, Stahl D, Magnusson V, Eliasson E, Agelii-Weber A, Stalhammar E, van Westen D, Deierborg T, Mansson KNT, Pizzagalli DA, Hammar A, Tornberg AB, Bjorkstrand J, Lindqvist D. Efficacy and target engagement of dopamine agonist pramipexole for anhedonic depression: a randomized placebo-controlled trial. Nat Med. 2026 Jul;32(7):2570-2578. doi: 10.1038/s41591-026-04465-9. Epub 2026 Jun 12.

    PubMed 42286321

  • Lindahl J, Asp M, Stahl D, Tjernberg J, Eklund M, Bjorkstrand J, van Westen D, Jensen J, Mansson K, Tornberg A, Svensson M, Deierborg T, Ventorp F, Lindqvist D. Add-on pramipexole for anhedonic depression: study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden. BMJ Open. 2023 Nov 30;13(11):e076900. doi: 10.1136/bmjopen-2023-076900.

    PubMed 38035737

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pramipexole in people with Anhedonia and Depression, 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 15 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 28 Apr 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Anhedonia symptoms (time frame: Baseline). The study lists 7 primary outcomes in all. 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 NCT05825235, which also lists 2 linked publications.

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 28 Apr 2026.

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