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van CCT (UK)

van CCT (UK)

Amitriptyline en mirtazapine bij langdurige slapeloosheid

- candidate number29464
- NTR NumberNTR7449
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-aug-2018
- Secondary IDs2017-003766-27 NL63470.029.17
- Public TitleAmitriptyline en mirtazapine bij langdurige slapeloosheid
- Scientific TitleThe DREAMING study: Efficacy of low dose amitriptyline and mirtazapine for insomnia disorder: a double-blind, randomized, placebo-controlled trial in general practice.
- hypothesisCompared to placebo a 16-week treatment with low dose amitriptyline and mirtazapine will improve subjective insomnia severity compared in insomnia disorder patients in general practice.
- Healt Condition(s) or Problem(s) studiedInsomnia, Insomnia
- 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.
- Exclusion criteriaGeneral 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

- 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2018
- planned closingdate
- Target number of participants156
- InterventionsThe investigational treatment, on top off usual care, consists of 16 weeks of one tablet of amitriptyline (10 mg) or mirtazapine (7.5 mg) or an identical appearing placebo per night. During treatment, participants visit their GP at least twice ( at week 3 and week 14) to evaluate their sleep and treatment satisfaction. In addition, at 3 weeks GP and participant can opt to double the dosage (2 units per night). At 14 weeks the GP and participant talk through stopping the trial medication at 16 weeks in case of single dosages and in case of double dosages, lowering from double to single dosage from 14 weeks onwards and stopping treatment at 16 weeks. During treatment and follow-up, care as usual of the participant’s GP continues, without restrictions.
- Primary outcomeThe primary outcome of the study is the insomnia severity as measured by the Insomnia Severity Index (ISI) (Morin e.a. 2011). The ISI is a 7-item questionnaire scored on a 5-point Likert scale reflecting the severity of both nighttime and daytime aspects of insomnia disorder as perceived by the participant in the last 2 weeks with scores ranging from 0 (no insomnia) to 28 (severe insomnia). The ISI is the recommended outcome measure in insomnia trials (Buysse e.a. 2006). Previous research has indicated that it is a valid and reliable instrument as outcome measurement. It possesses adequate internal consistency and is sensitive to changes in perceived sleep difficulties over time (Bastien e.a. 2001; Morin e.a. 2011). The total score can be interpreted as follows: absence of insomnia (0–7); sub-threshold insomnia (8–14); moderate insomnia (15–21); and severe insomnia (22–28) (Morin e.a. 2011). ISI will be evaluated at each time point: baseline, 6 weeks, 12 weeks, 20 weeks and 12 months.
- Secondary outcomeSecondary outcomes include subjective sleep quality quantified by sleep indices, daytime functioning and symptoms (fatigue, anxiety and depression), safety and treatment evaluation (side effects, withdrawal symptoms, treatment satisfaction and adherence). Treatment adherence will also be assessed by pill count. Care consumption is based on self-report and medical records in general practice.
- Timepointsbaseline, 6 weeks, 12 weeks, 20 weeks, 52 weeks.
- Trial web site
- status[default]
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryinsomnia is a major public health issue in general practice because of its high prevalence and substantial impact on patíents' well-being and the increased risk of comorbidily and huge (societal) costs associated with it. lnsomnia disorder patients often require sleep medication, despite Íirst cÀoice nonpharmacological treatments. These patients are at risk of benzodiazepine misuse and abuse, given the rapid devàopment of toierance and dependence. Effective and safe alternatives suitable Íor generàl practice aie therefore urgently needed. Clinical experience suggests that off-label low dose use of well-known sedating antidepressants as amitriptyline and mirtazapine, might be effective, non-addictive, and well-tolerated alternatives to treat insomnia disorder in general practice. Yet, evidence from placebo-controlled RCTs is lacking. Hence, this pragmatic trial concerns a phase three study to assess a new indication for well-known rnedication.
- Main changes (audit trail)
- RECORD27-aug-2018 - 9-sep-2018

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