Abstract

BackgroundDepressive and anxiety disorders have shown to be associated to premature or advanced biological aging and consequently to adversely impact somatic health. Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders. These interventions may, however, work through different pathophysiological mechanisms and could differ in their impact on biological aging and somatic health. This study protocol describes the design of an unique intervention study that examines whether both treatments are similarly effective in reducing or reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes).MethodsThe MOod Treatment with Antidepressants or Running (MOTAR) study will recruit a total of 160 patients with a current major depressive and/or anxiety disorder in a mental health care setting. Patients will receive a 16-week treatment with either antidepressant medication or running therapy (3 times/week). Patients will undergo the treatment of their preference and a subsample will be randomized (1:1) to overcome preference bias. An additional no-disease-no-treatment group of 60 healthy controls without lifetime psychopathology, will be included as comparison group for primary and secondary outcomes at baseline. Assessments are done at week 0 for patients and controls, and at week 16 and week 52 for patients only, including written questionnaires, a psychiatric and medical examination, blood, urine and saliva collection and a cycle ergometer test, to gather information about biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants. In addition, neurobiological alterations in brain processes will be assessed using structural and functional Magnetic Resonance Imaging (MRI) in a subsample of at least 25 patients per treatment arm and in all controls.DiscussionThis intervention study aims to provide a better understanding of the impact of antidepressant medication and running therapy on biological aging, metabolic stress and neurobiological indicators in patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment.Trial registrationTrialregister.nl Number of identification: NTR3460, May 2012.

Highlights

  • Depressive and anxiety disorders have shown to be associated to premature or advanced biological aging and to adversely impact somatic health

  • Lever-van Milligen et al BMC Psychiatry (2019) 19:425 (Continued from previous page). This intervention study aims to provide a better understanding of the impact of antidepressant medication and running therapy on biological aging, metabolic stress and neurobiological indicators in patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment

  • This study examines to what extent treatment-induced improvement in psychiatric status parallels with improvement of biological aging, metabolic stress and neurobiological abnormalities

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Summary

Methods

Study design The MOod Treatment with Antidepressant or Running (MOTAR) study is a 16-week intervention study with two treatment arms: 1) antidepressant medication and 2) running therapy (see Fig. 1). 160 patients with a depressive and/or anxiety disorder receive antidepressants or running therapy. Exclusion criteria are: 1) participation in regular (> 1/week) exercise and 2) medical contra-indications to running therapy or antidepressants (e.g. serious heart problems) as confirmed by a physician. Medication management is provided by a psychiatrist who meets each patient at study onset and at weeks 2, 6, 10 and 16 At these meetings, the psychiatrist evaluates treatment response and side effects, and titrates dosage (to a maximum of 20 mg) according to the multidisciplinary depression/anxiety guidelines until a clinically effective

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