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

Conditions

Major depression

Brief summary

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

Detailed description

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., 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)., 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., Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5., The test Probabilistic Reward Task (PRT)

Related papers

No related papers found yet.

Interventions

DRUGPRAMIPEXOLE

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
SHAPS-C (total SHAPS-C scores at baseline, week 3, week 6 and week 9).	—

Secondary

Measure	Time frame
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., 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)., 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., Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5., The test Probabilistic Reward Task (PRT)	—

Measure

Time frame

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., 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)., 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., Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5., The test Probabilistic Reward Task (PRT)

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Countries

Sweden

Outcome results

None listed