PRAMIPEXOLE for Major depressive disorder | Anhedonia

Inclusion criteria

• {"criterion_text":"- Age ≥18 years ≤75 years.\n- Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia.\n- Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).\n- Ongoing treatment with at least one antidepressant or mood stabilizing medication ≥ 4 weeks.\n- Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression).\n- The research subject has given informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- Pregnancy, breastfeeding or planned pregnancy (if female).\n- Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.\n- 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).\n- 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.\n- Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.\n- Participation in other treatment studies.\n- 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).\n- High suicide risk according to the overall clinical assessment of the research physician.\n- Ongoing substance abuse (within 6 months).\n- Diagnosis of current psychosis.\n- Known diagnosis of Emotionally Unstable Personality Disorder.\n- Treatment under LPT.\n- History of or a strong clinical suspicion of impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.\n- 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.\n- Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher)."}

Primary endpoints

• {"endpoint_text":"- SHAPS-C (total SHAPS-C scores at baseline, week 3, week 6 and week 9).","definition_or_measurement_approach":"Total SHAPS-C scores measured at baseline, week 3, week 6 and week 9."}

Secondary endpoints

• {"endpoint_text":"- HDRS6 scores (subscale of HDRS-17).","definition_or_measurement_approach":"HDRS6 subscale scores derived from the HDRS-17 instrument."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Physical activity, heart rate/oxygen saturation, heart rate variability and sleep metrics measured using activity meters (wearable activity monitors)."}
• {"endpoint_text":"- Total scores of DARS-SV-MOD, MADRS, AES, Insomnia Severity Scale GAD-7 and BBQ.","definition_or_measurement_approach":"Total scores on listed validated rating scales (DARS-SV-MOD, MADRS, AES, Insomnia Severity Scale, GAD-7, BBQ)."}
• {"endpoint_text":"- BOLD activity in the nucleus accumbens during fMRI (MID task).","definition_or_measurement_approach":"BOLD fMRI measurement in the nucleus accumbens during the Monetary Incentive Delay (MID) task."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Biomarkers of dopamine and inflammation assayed in blood and CSF; fMRI BOLD activity and diffusion tensor imaging connectivity analyses as specified."}
• {"endpoint_text":"- Gathering of adverse events.","definition_or_measurement_approach":"Collection and recording of adverse events (safety monitoring)."}
• {"endpoint_text":"- Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.","definition_or_measurement_approach":"Administration of a neuropsychological test battery (WAIS-IV, RBANS, D-KEFS, CPT-3) and PDQ-5 self-assessment."}
• {"endpoint_text":"- The test Probabilistic Reward Task (PRT)","definition_or_measurement_approach":"Performance measured on the Probabilistic Reward Task (PRT)."}

Sweden

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

04-12-2024

Processing Time Days

246

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden