Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Amitriptyline; Drug: Placebo

• Registration Number: NCT02127736
• Lead Sponsor: Winfried Rief

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Placebo	-
Control group	Placebo	-
Experimental group	Amitriptyline	-

Primary Outcome Measures

Name	Time	Method
Percentage of rapid eye movement (REM) sleep	5 nights during the study	assessed by polysomnography
Objective Total Sleep Time	5 nights during the study	assessed by polysomnography

Trial Locations

Locations (1)

Department of Psychology, Philipps University Marburg; 🇩🇪 Marburg, Hessen, Germany