Using Pramipexole to Treat Anhedonic Depression

Adjunctive Treatment With Pramipexole for Anhedonic Depression Symptoms in Depression - PRIME-PRAXOL

This study is testing if adding pramipexole to the usual antidepressant treatment can help people with depression who struggle to feel pleasure.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Region Skane (other)
• Locations: 1 site (Lund, Scania)
• Trial ID: NCT05355337 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of pramipexole, a dopamine receptor agonist, as an add-on treatment for patients experiencing anhedonia in the context of depression. The study involves 80 participants who will be randomly assigned to receive either pramipexole or a placebo for 9 weeks, while continuing their ongoing antidepressant treatment. The trial aims to address the treatment-resistant nature of anhedonia by utilizing a flexible dosing schedule and will also explore biomarkers and fMRI to predict treatment response. This approach is novel as it focuses specifically on anhedonia symptoms as the primary outcome measure.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with a diagnosis of unipolar depressive episode, bipolar disorder in a depressive phase, or dysthymia, who exhibit clinically significant anhedonia symptoms.

Not a fit: Patients who are currently pregnant, at high risk of suicide, or have a diagnosis of a psychotic disorder will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from anhedonic depression by providing an effective therapeutic option.

How similar studies have performed: While there is preliminary evidence from pilot studies supporting the use of pramipexole for anhedonia, this specific approach in a randomized controlled trial setting is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age between 18 years and 75 years.
* Informed consent
* Diagnosis of unipolar depressive episode or bipolar disorder in depressive phase or dysthymia.
* Clinically significant anhedonia symptoms: SHAPS self-report score 3 or 4 on ≥ 3 items.
* Ongoing stable treatment with at least one antidepressant or mood stabilizing medication for at least 4 weeks. Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression)

Exclusion Criteria:

* Ongoing pregnancy, breastfeeding or planned pregnancy.
* High risk of suicide according to the overall clinical assessment of the research physician.
* Substance abuse within the last 6 months.
* Diagnosis of current psychotic disorder.
* Known diagnosis of Emotionally unstable personality disorder.
* Ongoing treatment under the Compulsory Psychiatric Care Act.
* Medical history or strong clinical suspicion of impulse control disorder (including current binge-eating disorder) or a current Attention Deficit Hyperactivity Disorder diagnosis with hyperactivity.
* Diagnosis of intellectual disability, dementia, or other circumstances that makes it difficult to understand the meaning of participating in the trial and provide informed consent.
* Diagnosis of renal failure (eGFR \< 50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure New York Heart Association Class II or greater).
* Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
* Ongoing treatment with electroconvulsive therapy (ECT), ketamine or repetitive transcranial magnetic stimulation (rTMS), except 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 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, obesity surgery affecting the absorption of extended-release tablets.
* Ongoing treatment with drugs that affect plasma levels of pramipexole or have similar or antagonistic mechanism of action as pramipexole are not allowed. Ongoing treatment with neuroleptics are not allowed except for low-dose quetiapine 27 (≤150 mg/day) since it has very low binding to dopamine receptors at such low doses.
* 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)

Conditions: Psychiatric Disorders Mood, Anhedonia, Depression, Pramipexole