Amitriptyline en cognitieve gedragstherapie bij langdurige slapeloosheid voor patiënten met een medische aandoening

• Conditions: Insomnia disorder

• Registration Number: NL-OMON25122
• Lead Sponsor: Hospital Gelderse Vallei

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

Adults aged 18 – 85 years visiting the outpatient clinic department of neurology.
- Presence of insomnia disorder conform DSM-5, i.e. sleep problems in at least 3 nights a week, for at least 3 months with consequences for daytime functioning, the sleep problem cannot be better explained by or occurs exclusively during the course of another sleep disorder
- Score of =10 on the Insomnia Severity Index (ISI) (Morin e.a. 2011)
- Have a medical condition and / or chronic pain (> 3 months).

Exclusion Criteria

Study related exclusion criteria
- Habitual night shift worker
- Untreated sleep related breathing disorder
- Wish to continue over-the-counter sleep aids as melatonin and medicinal cannabis
- Use of off-label amitriptyline for insomnia in the past year
- Being unable to follow study instructions and fill out the study questionnaires (in Dutch)
- A known diagnosis of dementia
- History of delirium
- Pregnancy, lactation or wish to become pregnant in the coming 6 months
- Terminal illness (prognosis < 1 year)
- Suicide risk
- Epilepsy
- Ocular Hypertension / Glaucoma
- The presence of a severe psychiatric disorder not in remission or adequately treated.
- Current alcohol or drug abuse/addiction (benzodiazepine excluded).
- Participation in other interventional medical scientific studies

Potential drug-drug interactions for amitriptyline
- Current use of psychopharmaceuticals other than benzodiazepine (antidepressants:SSRI’s (e.g. bupropion, fluoxetine, paroxetinefluvoxamine), MAOinhibitors, St John’s wort, anticonvulsants (e.g. carbamazepine)
- Current use of antimycotica (e.g. terbinafine)

Contra-indications for amitriptyline following pharmacological guidelines as used in clinical practice.
- Allergy for amitriptyline
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified