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Does Psycho-Motor Therapy Ameliorate Depression and Alter Striatal Dopaminergic Signaling and Brain Neuronal Connectivity During Depression?

Does Psycho-Motor Therapy Ameliorate Depression and Alter Striatal Dopaminergic Signaling and Brain Neuronal Connectivity During Depression? - FIT-BRAIN

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48201
Enrollment
22
Registered
2019-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Depression

Interventions

Subjects with MDD will enter a 3-month in-house supervised PMTERGO at the Psychiatry clinic of the Amsterdam UMC (AMC location).

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male; * Age 30-69 years; * BMI 18.5-30 kg/m2; * Stable body weight (i.e.

Exclusion criteria

Exclusion criteria: - General contraindications for MRI (such as claustrophobia); - Occupational radiation exposure; - Any significant somatic disease (e.g. cancer, diabetes, gastrointestinal disease, etc.); - History of cerebro- and/or cardiovascular diseases; - Excessive alcohol use (>21 units/week), or any current use of any recreational drug. - Indications of disturbed glucose homeostasis, suggestive of glucose resistance (>7.8 mmol/L will be excluded); - Shift workers; - Severe insomnia; - Psychotic or bipolar MDD; - Currently undergoing treatment with antipsychotics; - Currently undergoing electroconvulsive therapy treatment.

Design outcomes

Primary

MeasureTime frame
Primary objectives * To determine if 3-month PMTERGO decreases depressive symptoms in subjects with MDD * To determine if 3-month PMTERGO alters in vivo striatal DRD2/3 BP compared to pre-intervention levels in subjects with MDD—

Secondary

MeasureTime frame
Secondary objectives: * To determine if medium-intensity ergocycle exercise acutely lowers in vivo striatal DRD2/3 BP in subjects with MDD compared to pre-ergocycle exercise levels. * To determine whether 3-month PMTERGO modulates reward processing between key reward-related brain regions. * To determine correlations between acute medium-intensity ergocycle exercise-induced changes in neuroendocrine hormones and metabolites and acute changes in in vivo striatal DRD2/3 BP. * To assess 3-month PMTERGO-induced changes in neuropsychological function, lifestyle and dietary patterns. * To determine correlations between 3-month PMTERGO-induced changes in fasting neuroendocrine hormones and in vivo striatal DRD2/3 BP.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)