Sleep, circadian rhythmicity, mood and pain perception in patients with affective and affect regulation disorders and healthy controls

Recruiting

Conditions: Depression, Schizophrenia, borderline personality disorder
F32
F33
F34.1
F43.2
F20-F29
F60.31
Depressive episode
Recurrent depressive disorder
Dysthymia

Registration Number: DRKS00010154

Lead Sponsor: Vitos-Klinikum Gießen-MarburgÄrztlicher Direktor

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

Outpatients, inpatients or day hospital patients with one of the following mental disorders: A) depressive disorder: Depressive episode (ICD-10: F32), recurrent depressive disorder (ICD-10: F33), dysthymia (ICD-10: F34.1), adjustment disorder with depressed mood (ICD-10: F43.2) or B) Schizophrenic disorder according to ICD-10 F2 or C) emotionally instable personality disorder (ICD-10: F60.3). D) Healthy subjects without current or past mental disorders (excepting ICD-10: F17). Further criteria: E) unmedicated or stable on psychotropic medication for at least 5 days, F) consent capacity and voluntary treatment and G) no other relevant physical illness or drug use.

Exclusion Criteria

For the patient groups:
A) Mental disorders of the ICD-10 groups F0, F1 (except F17), F5-F7. B) Endocrine diseases (especially of the adrenal Cortex, thyroid hyper- or hypofunction), C) Neurological diseases with severe somatosensory deficits, D) Organic sleep disoders, E) Current or recent (3 months at maximum) treatment with steroids (except contraceptives), F) Pregnancy, G) Recent (within the last four weeks) disruptions of sleep-wake rhythmicity due to exogenous conditions such as shift work or travel across time zones with jet lag.
For healthy controls: a current or past mental disorder (except ICD-10: F17) as well as the criteria B to G as described above for the patient groups

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Actigraphically measured sleep parameters, rest-activity rhythmicity (ratio between activity and inactivity state, the so-called relative amplitude), and measures of pain processing (pain complaints, pain sensitivity) in the course of 10 days. Measures of pain processing: quality and intensity of pain complaints on each evening and morning by a questionnaire (short version of the McQuill Pain Questionnaire, MPQ); Measures of pain sensitivity: pressure pain thresholds on each second evening and the following morning (i.e. five evening-morning sequences); thermal pain thresholds from day 2 (evening) to day 3 (morning) and from day 7 (evening) to day 8 (morning).

Secondary Outcome Measures

Name	Time	Method
Measures of current mood states (Mood checklist based on categories and adjectives, BSKE), circadian and stress-related measures of the hypothalamic-pituitary-adrenal (HPA) axis activity and the sympathetic nervous system (cortisol, alpha-amylase): saliva samples (Salivette) on each second evening (one sample) and subsequent morning (four times within 60 minutes), daily stress ratings by a diary, personality traits such as neuroticism and chronotype by questionnaires (NEO Five-Factor Inventory, NEO-FFI; Morningness-Eveningness questionnaire, MEQ) at day 0 (baseline), neuropsychological parameters of cognitive speed and flexibility by the Trial Making Test (TMT-A and TMT-B) on the evening on day 1 and the morning on day 2.