Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-54
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood disorders or sleep inertia. Controls will be patients referred to the Sleep Disorders and Acupuncture Unit for polysomnography as part of the screening process for a sleep disorder. Only controls presenting an apnea-hypopnea index \< 15/h, a periodic leg movements index during sleep \< 15/h and a total sleep time ≥ 6 hours on the video-polysomnography will be analyzed.
Eligibility criteria
Qualifiers
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Ability to understand, write and read French Inclusion criteria for patients with major depression
Diagnosis of depression according to DSM-5 criteria
Disqualifiers
The patient is participating in an interventional study
The patient is under safeguard of justice or state guardianship
Unweaned from the following medications for at least 5 half-lives prior to inclusion: wake-promoting or psychostimulant drugs (modafinil, methylphenidate, mazindol, amphetamine, pitolisant, solriamfetol, sodium oxybate), neuroleptics, hypnotics, antidepressants, anxiolytics, antiepileptics, budipine, dopamine agonist and antagonist antiemetics (except domperidone), opiates, gabapentin, pregabalin, benzodiazepines, Z-hypnotics (zolpidem and zopiclone), monoamine oxidase inhibitors, catechol-O-methyltransferase or sedative antihistamines.
Patients with central nervous system diseases: Parkinson's disease, mild cognitive impairment and dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, epilepsy, history of head trauma with loss of consciousness.
Trial design
Treatments tested in this trial
- Psychomotor vigilance task
- Video-polysomnography
- Sleep and activity monitoring
Treatment groups
110 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov