Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Amitriptyline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Amitriptyline<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Control group<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Total Sleep Time | assessed by polysomnography | 5 nights during the study | 
| Percentage of rapid eye movement (REM) sleep | assessed by polysomnography | 5 nights during the study |