Adjuvant treatment with Pramipexole for anhedonia symptoms in depression - PRIME-PRAXOL

Phase 3

Recruiting

Conditions: Major depression

Registration Number: 2024-512495-35-00

Lead Sponsor: Region Skane

Brief Summary: Will treatment with pramipexole at the highest possible dosage (without intolerable adverse reactions, max 3.15 mg base) reduce anhedonia symptoms over a nine-week period compared to placebo treatment?

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

Age ≥18 years ≤75 years.

Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia.

Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).

Ongoing treatment with at least one antidepressant or mood stabilizing medication ≥ 4 weeks.

Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression).

The research subject has given informed consent to participate in the study.

Exclusion Criteria

Pregnancy, breastfeeding or planned pregnancy (if female).

Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.

Ongoing or planned 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 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, bariatric surgery with a known impact on 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).

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 or a strong clinical suspicion of impulse control disorder (including current bingeeating 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 (eGFR < 50 ml/min/1,73 m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SHAPS-C (total SHAPS-C scores at baseline, week 3, week 6 and week 9).		SHAPS-C (total SHAPS-C scores at baseline, week 3, week 6 and week 9).

Secondary Outcome Measures

Name	Time	Method
HDRS6 scores (subscale of HDRS-17).		HDRS6 scores (subscale of HDRS-17).
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, sleep awakening, wakefulness, time in deep sleep, sleep efficiency. All variables are measured using activity meters.		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, sleep awakening, wakefulness, time in deep sleep, sleep efficiency. All variables are measured using activity meters.
Total scores of DARS-SV-MOD, MADRS, AES, Insomnia Severity Scale GAD-7 and BBQ.		Total scores of DARS-SV-MOD, MADRS, AES, Insomnia Severity Scale GAD-7 and BBQ.
BOLD activity in the nucleus accumbens during fMRI (MID task).		BOLD activity in the nucleus accumbens during fMRI (MID task).
Biomarkers related to dopamine and inflammation, measured in blood and CSF. BOLD activity in the nucleus accumbens during MID task fMRI and connectivity during diffusion tensor imaging.		Biomarkers related to dopamine and inflammation, measured in blood and CSF. BOLD activity in the nucleus accumbens during MID task fMRI and connectivity during diffusion tensor imaging.
Gathering of adverse events.		Gathering of adverse events.
Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.		Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.
The test Probabilistic Reward Task (PRT)		The test Probabilistic Reward Task (PRT)