Obesity and depression: pathogenetic role of sleep and wakefulness regulation, motoric activity level and neurochemical aspects

Recruiting

Conditions: E66
F32
Obesity
Depressive episode

Registration Number: DRKS00004190

Lead Sponsor: niversitätsklinikum Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vigilance regulation is the primary outcome.<br>It will be assessed using EEG and vigilance stages will be classified using a Wakefulness-Assessment-Tool.<br>There will be a baseline and a follow-up assessment after 6 months for all of the 300 subjects.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are:<br><br>Hormone, neuropeptid- und cytokine levels will be assessed using blood samples.<br><br>Motor activity will be assessed and analyzed using accelometry (Sensewear devices and software).<br><br>Affektive und behavioural parameters will be assessed and analyzed using questionnaires (Beck-Depression-Inventory II, Hamilton Depression Rating Scale)<br><br>Secondary outcomes will be assessed at baseline and at follow-up after 6 months.