Randomized controlled effects of a whole body vibration training on clinical symptoms and neurobiology in adolescent inpatients with major depressive episode

Not Applicable

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00011772
• Lead Sponsor: niklinik Köln, Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

participants have to meet ICD-10 criteria of depressive disorder (ICD-F32,ICD-F33)
- recidivating depressive disorder
- bipolar disorder with actual depressive Episode without psychotic symptoms
- age 13 to 18
- informed consent from participants and participants’ parents
- no medication or on stable Long-term medication

Exclusion Criteria

- schizophrenia, personality disorders, autism spectrum disorders, other psychotic disorders, schizo-affective disorder, acute suicidality
- unsufficient german language skills
- IQ < 70
- Epilepsy (of subject current or in medical history, or of relatives
- serious head injuries and head sugeries
- Current substance abuse
- Body Mass Index < 16 kg/sqm
- diseases causing restrictions to physical activity and the use of vibration devices,
malignant diseases
- permanent long-term psychiatric medication or medication with inherent psychotropic effects (anticonvulsants, steroids, methylphenidate, amphetamine, antidepressants, neuroleptics, benzodiazepines, mood-stabilizer)
- Patients with Morbus Addison or non-substituted hypothyroidism
- Current pregnancy
- metal implants (e.g. pacemaker implantation)
coffee and cigarette consumption 24 hours until neurophysiological investigations start
- intake of stimulants medication the day of Investigation or 48 h Prior to neurophysiological and MRI Investigation in case of Retard medication

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- zu t0, t2 (after 6 weeks), t3 (after 14 weeks) und t4 (after 20 weeks): CDRS-R (Children Depression Rating Scale - Revised), blinded clinician rating

Secondary Outcome Measures

Name	Time	Method
- t0, t2, t3, t4: Becks Depressions inventar (BDI)<br>- t0, t2: Saliva Cortisoll, <br>- t0, t2, t3: Cytokines (IL-6, TNF Alpha), BDNF, IGF 1 (Blood), <br>- t0, t2, t3: Neurocognition (CANTAB®)<br>- t0: K-SADS (ICD-10 Assessment IV)<br>- t0, t2, t3, t4: other questionnaires (CTQ (Child Trauma questionnaire), EZK (Eigenzustandsskala), WKV (wahrgenommene körpergebunden Verfassung), MSES (Magglinger Sport Enjoyment Scale), CBCL (Child Behavior Checklist), YSR (Youth Self Report), JTCI( Junior Temperament Character Inventory), DISYPS SBB-DES (Depression Self Rating scale), PHOKI (Phobias), DIKJ (Depressions inventar children and adolescents), Collins (Self perception), PACES (movement), Sportmotivation, DISYPS FBB-DES, SSV und ADHS (other Rating by parents and nurses about MDD, ADHD and social behavior disorder), SES (socioeconomic Status)<br>-t0, t2, t3: neurophysiological Parameters (TMS-EEG)<br>- t0, t3: cMRT<br>- t0: BDNF Polymorphisms