Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Healthy Participants Clinical Trial

Official title:

Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127736
• Other study ID #: PSG40
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: September 1, 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Philipps University Marburg
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Amitriptyline

• Placebo

Locations

Country	Name	City	State
Germany	Department of Psychology, Philipps University Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Winfried Rief

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Total Sleep Time	assessed by polysomnography	5 nights during the study	No
Primary	Percentage of rapid eye movement (REM) sleep	assessed by polysomnography	5 nights during the study	No