Long-term effects of pramipexole for treating anhedonic depression
Long-term Efficacy and Tolerability of add-on Pramipexole for Anhedonic Depression - an Open Label Follow-up Study
This study is testing if the medication pramipexole can help people with anhedonic depression feel better over a longer time, especially for those who didn't respond well to other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund, Scania) |
| Trial ID | NCT05825235 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term efficacy and safety of pramipexole as an add-on treatment for patients suffering from anhedonic depression. Anhedonia, characterized by a lack of pleasure and motivation, is often resistant to standard depression treatments and is linked to dopaminergic dysfunction. In this open-label follow-up, participants who previously took part in a randomized controlled trial will either continue their pramipexole treatment or start it if they were on placebo. The study will assess the impact of pramipexole on symptoms of anhedonia over an extended period.
Who should consider this trial
Good fit: Ideal candidates are individuals who previously participated in a related randomized controlled trial and exhibit clinically significant anhedonia.
Not a fit: Patients with high suicide risk or ongoing substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with anhedonic depression by alleviating their symptoms.
How similar studies have performed: Previous studies have shown promise in using dopaminergic agents for treating anhedonia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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". Exclusion Criteria: * 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. * 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).
Where this trial is running
Lund, Scania
- Region Skåne — Lund, Scania, Sweden (Recruiting)
Study contacts
- Study coordinator: Daniel Lindqvist, MD, PhD
- Email: Daniel.lindqvist@med.lu.se
- Phone: +4646173885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.