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Long-term efficacy and tolerability of add-on pramipexole for anhedonic depression – an open label follow-up study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502270-17-00
Enrollment
80
Registered
2023-02-09
Start date
2023-04-21
Completion date
Unknown
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

Total SHAPS-C scores

Detailed description

HDRS6 scores, 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)., Total scores of DARS, MADRS-S, Insomnia Severity Scale, AES, GAD-7 and BBQ., Adverse events and side effects, fMRI, blood and CSF biomarkers from the RCT as treatment predictors., Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.

Interventions

DRUGPRAMIPEXOLE

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total SHAPS-C scores

Secondary

MeasureTime frame
HDRS6 scores, 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)., Total scores of DARS, MADRS-S, Insomnia Severity Scale, AES, GAD-7 and BBQ., Adverse events and side effects, fMRI, blood and CSF biomarkers from the RCT as treatment predictors., Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026