The DREAMING study: Efficacy of low dose amitriptyline and mirtazapinefor insomnia disorder

Phase 1

• Conditions: Insonnia disorder; MedDRA version: 20.0Level: LLTClassification code 10078083Term: Insomnia disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-003766-27-NL
• Lead Sponsor: VU University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-05
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

- Adults aged 18-85 years and registered as patient in one of the
participating general practices.
- Presence of insomnia disorder conform DSM-5, i.e. sleep problems
(including problems maintaining sleep) in at least 3 nights a week
during at least 3 months, with consequences for daytime functioning.
- Request for long-term and/or frequent sleep medication put to their
GP because non-pharmacological treatment according to the Dutch
(NHG) general practice guideline is deemed insufficient by patient and
GP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

General exclusion criteria
-Isolated problem falling asleep (without problems maintaining sleep)
-Insomnia secondary to another medical condition, e.g. OSAS, comorbid major depression, chronic pain
-Habitual shift worker doing night shifts
-Wish to continue (over-the-counter) melatonin
-Use of off-label amitriptyline or mirtazapine for insomnia in the past year
-Terminal illness
-Suicide risk
-Pregnancy, lactation or wish to become pregnant in the coming 6 months
-Vulnerability due to unstable health situation according to GP.
-Being unable to follow study instructions and fill out the study questionnaires (in Dutch)
-Participation in other interventional medical scientific studies

Contra-indications
-Allergy for amitriptyline or mirtazapine
-Cardiac arrhythmia / blockade / Long QT syndrome / Brugada syndrome / Family history of acute cardiac death
-Recent myocardial infarction (within the past 90 days) / Angina pectoris / coronary insufficiency
-Severe renal insufficiency (GFR < 10)
-Severe liver dysfunction
-Epilepsy
-Ocular Hypertension / Glaucoma
-Bipolar affective disorder
-Current alcohol or drug abuse/addiction

Potential drug-drug interactions
-Current use of psychopharmaceuticals (including anxiolytics as e.g. benzodiazepines, antidepressants including St John’s wort and, anticonvulsants )
-Current use of antimycotics (all types)
-Certain enzyme inductors, antiretroviral drugs, cimetidine and clonidine. (All of these are not commonly used and will be excluded by the prescription check by the GP and/or the final check by the pharmacist).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified