Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Winfried Rief

Status: Completed

Conditions: Healthy Participants

Treatments: Drug: Amitriptyline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02127736

PSG40

Details and patient eligibility

About

The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 years to 69 years
• willingness to refrain from alcohol consumption throughout the study
• regular sleeping habits
• fluent in German language
• is not dependent on driving to get to the study center
• provide written informed consent
• ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion criteria

• Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history

  • allergies to amitriptyline hydrochloride or any of its ingredients
  • acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
  • urinary retention
  • delirium
  • untreated closed-angle glaucoma
  • prostatic hyperplasia
  • pyloric stenosis
  • paralytic ileus
  • suicidal thoughts
  • liver/ kidney/ pulmonary insufficiency
  • myasthenia gravis
  • hypokalemia
  • bradycardia
  • coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
  • increased risk of seizures/ history of seizures
  • substance dependence syndrome/ history of substance dependence syndrome

• Allergies to ingredients of placebo or novel-tasting drink (CS)

• currently pregnant (verified by urine pregnancy test) or lactating

• patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)

• patients suffering from a medical condition (assessed by the study physician)

• Concomitant medication interfering with study medication intake due to potential interactions

• participation in any other clinical trial 3 months prior to visit 1

• employee of the Sponsor or the principal investigator

Trial design

0 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Treatment:

Drug: Amitriptyline

Drug: Placebo

Control group

Placebo Comparator group

Treatment:

Drug: Placebo