Major Depression Disorder according to DSM-V
Conditions
Interventions
Group 1: Patients with Depression Diagnosed According to DSM-V
Assessments conducted using questionnaires, fMRI, and a pulse oximeter (sleep monitoring) for 6 weeks in 4 sessions, each lasting 2-3 hou
Sponsors
Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: We will include an even number of males and females for both the group of patients and controls. Inclusion criteria for patients: Diagnosis of MDD according to DSM-V. Inclusion criteria for controls: Aged 18 years or older, but not older than 60 years and matched according to age and sex (2 patients: 1 controls).
Exclusion criteria
Exclusion criteria: Unable to give informed consent, pregnant women, individuals with other psychiatric disorders such as alcohol and drug dependency, organic psychiatric disorders, personality disorder, bipolar disorder, schizophrenia, current depressive episode with psychotic symptoms and suicidality. Neurological disorders and diseases affecting the brain function will further be excluded (e.g. manifest hypo- or hyperthyreodism). We will also exclude primary chronic insomnias, sleep related breathing disorders (sleep apnea) and sleep movement disorders (restless legs syndrome, bruxism) that affect sleep fragmentation. Similarly, we will exclude sleep related psychotherapeutic treatments, such as sleep deprivation and light therapy (influencing sleep indirectly). Only psychoeducation on sleep hygiene is allowed. Sleep apnea will further be detected and patients will be excluded in this case by measurements from the SleepAI system. Also, restless legs syndrome will be detected in the first night by an additional leg sensor and thus can objectively be assessed and patients can subsequently be excluded. Moreover, patients taking benzodiazepines or sleeping tablets at baseline will be excluded. Since the new national treatment guideline has a negative recommendation for use of sleeping medication and benzodiazepines for moderately severe depressive episodes, the number of patients receiving sleeping medication and benzodiazepine will be lower and we will be able to recruit enough patients, who are currently not taking sleeping tablets or benzodiazepines. Throughout the course of the follow-up period, benzodiazepines will be allowed for agitation in case of emergency. Exclusion criterion for controls: Diagnosis of MDD according to DSM-V.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fMRI data from T0 to T2. Change in depression severity as measured by MADRS from T0 to T1 and T2. Change in sleep quality measured by pulse oximeter from T0 to T1 and T2 and PSQI from T0 to T2 and T3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of depression and sleep parameters using questionnaires: Depression severity will be assessed using MADRS (Montgomery Asberg Depression Rating Scale) at all time points. Sleep quality will be assessed using PSQI (Pittsburgh Sleep Quality Index) at T0, T2 and T3. fMRI activity and connectivity at T0 and T2. | — |
Countries
Germany
Contacts
Public ContactUte Habel
Uniklinik RWTH Aachen
Outcome results
None listed