Status:

RECRUITING

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.

Lead Sponsor:

Woolcock Institute of Medical Research

Conditions:

Insomnia

Eligibility:

All Genders

40-65 years

Phase:

PHASE2

Brief Summary

The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are: * D...

Detailed Description

This is a randomised placebo-controlled cross-over study of a dual orexin receptor antagonist (DORA) versus placebo in adults with insomnia. To be enrolled in the study, participants are required to ...

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI.
  • Able to provide informed electronic consent.
  • Fluent English literacy.
  • Adults aged between 40-65 years.

Exclusion Criteria:

  • People highly dependent on medical care as determined by a medical officer.
  • Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index>15, ongoing effectively treated sleep apnoea with insomnia will be allowed).
  • Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders.
  • History of attempted suicide or current suicide ideation (indicated by a score >0 on Q9 of the Patient Health Questionnaire-9) at pre-screening.
  • Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA)
  • Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation.
  • Pregnancy or lactation. Women will be advised to use contraception for the duration of the study and a urine pregnancy test will be performed when necessary.
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures.
  • Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
  • Concomitant use of medicines that are inhibitors (e.g., diltiazem, fluvoxamine, fluconazole, itraconazole, verapamil), or moderate to strong inducers of CYP3A4 (e.g., carbamazepine, modafinil, phenytoin, rifampicin, St John's Wort)
  • Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants.
  • Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
  • Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
  • Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year.
  • Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
  • Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial.
  • Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period).
  • Allergy to lactose.

Key Trial Info

Start Date :

May 13 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06823752

Start Date

May 13 2025

End Date

April 1 2026

Last Update

October 3 2025

Active Locations (1)

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Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia, 2113