– HealthFit – The effects of high-intensity interval training versus an active control group on depressive symptoms and their concurrent biomarkers in outpatients diagnosed with Major Depressive Disorder

Not Applicable

Conditions: Major Depressive Disorder

Registration Number: DRKS00031230

Lead Sponsor: Deutsche Sporthochschule Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 44

Inclusion Criteria

Participants must be native German speakers diagnosed with major depressive disorder by certified clinicians and be outpatients.
To be recognised as suffering from Major Depressive Disorder (from mild to moderate), participants need to state at least five and a maximum of seven of nine symptoms of the DSM-5 depression definition nearly every day for at least two weeks.

Medication: None or stable for at least two weeks before inclusion. If benzodiazepine or benzodiazepine-like medication: last intake maximum 24h before the beginning of the study. Assessment of the level of anti-depressive medication in the peripheral blood at inclusion and after completion of the study

Exclusion Criteria

- Physical exercise: Engaged in >2 h per week.
- Body Mass Index: <18 and > 30 kg/m2
- Comorbid diseases: Metabolic, hormonal, renal, intestinal, neuroendocrine diseases, chronic infection, drug addiction, or other diagnosed psychiatric disorders (e.g., bipolar disorder, personality disorder, psychosis)
- Smoking: >20 cigarettes per day in the past three months
- Alcohol use: AUDIT sum score >19
- Supplement: tryptophan-related supplements
- Others: Pregnancy, Breastfeeding, Night-work shift

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study primarily aims to test if ten weeks of high-intensity interval training can concordantly regulate inflammatory-mediated changes in the kynurenine pathway and depressive symptoms in a sample of Major Depressive Disorder outpatients when compared to supervised active controls. <br>These markers will be gathered at rest on fasted participants at baseline, after 5 weeks of training, and after 10 weeks of training (end of the intervention). The inflammation markers will be measured with Enzyme-Linked Immunosorbent Assay. The kynurenine markers will be assessed with High-Performance Liquid Chromatography-associated mass spectrometry. The depression symptoms will be assessed with self-reports and Clinician interviews.

Secondary Outcome Measures

Name	Time	Method
An explorative analysis of methylation levels in promoters and polymorphic regions of the genes encoding for the major enzymes of the tryptophan pathways