Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A

Details

• Lead Sponsor: Winfried Rief
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

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