NCT06443216

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
2mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

May 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

May 22, 2024

Last Update Submit

July 22, 2024

Conditions

Major Depressive DisorderHealthy

Outcome Measures

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.

    Up to three weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients with major depressive disorder according to ICD-10 criteria

Device: Auditory closed-loop stimulationDevice: Sham stimulation

Healthy Group

EXPERIMENTAL

Healthy controls

Device: Auditory closed-loop stimulationDevice: Sham stimulation

Interventions

Auditory closed-loop stimulationDEVICE

Auditory closed-loop suppression of slow wave sleep

Experimental GroupHealthy Group
Sham stimulationDEVICE

No auditory stimulation

Experimental GroupHealthy Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group

You may not qualify if:

  • 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.
  • Organic sleep disorders including relevant sleep apnea (AHI\>15/h), periodic limb movement disorder (PLMS index\>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
  • Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included
  • Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation
  • Contraindications for tDCS or TMS studies, including but not limited to metal in the head/ brain or epilepsy
  • Hearing impairment or tinnitus (auditory stimulation study)
  • Inability to follow the procedures of the study (for example due to language problems)
  • Left-handedness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Christoph Nissen, Prof. Dr. med.

CONTACT

+41.22.305.45.38christoph.nissen@hug.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 5, 2024

Study Start

July 22, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

CH(1)