Sleep Modulation to Treat Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorChristoph Nissen
About this trial
Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent
MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group
Disqualifiers
Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
Known pregnancy
Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
Relevant neurological disorders, including epilepsy, stroke, etc.
Trial design
Design model
Crossover
Treatments tested in this trial
Auditory closed-loop stimulation
DeviceAuditory closed-loop suppression of slow wave sleep
Sham stimulation
DeviceNo auditory stimulation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 2 interventions
Group B: Healthy GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Montgomery Åsberg Depression Rating Scale
Measure of the severity of depressive symptomatology The scores range between 0 to 60. The higher the score, the more symptamology of depression the subjects presents.
Time frame
Up to three weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christoph Nissen
Lead sponsor
University of Geneva, Switzerland
Sponsor institution
Source ClinicalTrials.gov