Status:

COMPLETED

Mirtazapine for Chronic Insomnia in Older Adults

Lead Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborating Sponsors:

Quebec Researchnetwork on aging

Conditions:

Chronic Insomnia

Eligibility:

All Genders

65+ years

Phase:

PHASE1

Brief Summary

Insomnia is highly prevalent in the older adult population. The pharmacolgical management of chronic insomnia includes benzodiazepines and Z-drugs (zolpidem, zopiclone). Although these drugs are indic...

Eligibility Criteria

Inclusion

  • Age 65 years and older
  • A report of sleep initiation or maintenance problems
  • An adequate opportunity and circumstances to sleep,
  • To have at least one daytime consequence in relation to sleep complaint.
  • Sleep disorder and daytime consequences occur at least 3 times a week.
  • Duration of sleep disorder and daytime consequences for at least 3 months
  • Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia.

Exclusion

  • Contrindication to mirtazapine
  • Use of drug for insomnia
  • Cognitive Behavioural Therapy for insomnia
  • Use of Melatonin
  • Active psychiatric illness
  • Parkinson's disease
  • Major Neurocognitive disorders
  • More than one fall in the last 3 months

Key Trial Info

Start Date :

October 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05247697

Start Date

October 1 2022

End Date

July 30 2024

Last Update

August 12 2024

Active Locations (1)

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1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X0C1