E66 F32
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Arm 1: BMI > 35 and no history of depression Arm 2: BMI > 35 and current depressive episode Arm 3: BMI < 30 and current depressive episode Arm 4: BMI < 30 and no history of depression
Exclusion criteria
Exclusion criteria: other DSM-IV Axis 1 disorders use of illegal drugs abuse of alcohol within the past 6 months a history of head injury with loss of consciousness exceeding one hour major somatic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vigilance regulation is the primary outcome. It will be assessed using EEG and vigilance stages will be classified using a Wakefulness-Assessment-Tool. There will be a baseline and a follow-up assessment after 6 months for all of the 300 subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: Hormone, neuropeptid- und cytokine levels will be assessed using blood samples. Motor activity will be assessed and analyzed using accelometry (Sensewear devices and software). Affektive und behavioural parameters will be assessed and analyzed using questionnaires (Beck-Depression-Inventory II, Hamilton Depression Rating Scale) Secondary outcomes will be assessed at baseline and at follow-up after 6 months. | — |
Countries
Germany
Contacts
IFB AdipositasErkrankungen