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Completed

NCT Number: NCT02127736

Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amitriptyline

Drug

Placebo

Drug

Primary outcomes

  1. Objective Total Sleep Time

    Time frame: 5 nights during the study

    assessed by polysomnography

  2. Percentage of rapid eye movement (REM) sleep

    Time frame: 5 nights during the study

    assessed by polysomnography

Sponsors and collaborators

Lead sponsor

Winfried Rief

Other

Registry information

Important dates

Primary completion
2014
Study completion
2014
First posted
May 1, 2014
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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