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

Withdrawn

Conditions: Depression
10027946

Registration Number: NL-OMON48201

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

* Male;
* Age 30-69 years;
* BMI 18.5-30 kg/m2;
* Stable body weight (i.e. <10% change) for three months prior to study
inclusion;
* Consistent intake of one antidepressant class [e.g. selective serotonin
reuptake inhibitors (SSRIs) or tricyclic antidepressants (TCAs)] for two weeks
prior to study inclusion.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives<br /><br>* To determine if 3-month PMTERGO decreases depressive symptoms in subjects<br /><br>with MDD<br /><br>* To determine if 3-month PMTERGO alters in vivo striatal DRD2/3 BP compared to<br /><br>pre-intervention levels in subjects with MDD</p><br>

Secondary Outcome Measures

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