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CompletedNCT02127736Updated Sep 3, 2014

Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

An interventional study of Amitriptyline and Placebo in Healthy Participants, sponsored by Winfried Rief. Completed at 1 site in Germany. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-09-03.

Sponsored by Winfried Rief · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

This is the only study on the registry with Winfried Rief as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All

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

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
05

Study design

Phase
Not applicable

Study arms

  • Experimental
    Experimental group

    Drug: Amitriptyline · Drug: Placebo

  • Placebo comparator
    Control group

    Drug: Placebo

Interventions

  • DrugAmitriptyline
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Objective Total Sleep Time

    assessed by polysomnography

    Time frame: 5 nights during the study

  2. Percentage of rapid eye movement (REM) sleep

    assessed by polysomnography

    Time frame: 5 nights during the study

07

Study locations

1 site
  • Department of Psychology, Philipps University Marburg
    Marburg, Hessen 35032, Germany
08

References and documents

Publications

  • Rheker J, Rief W, Doering BK, Winkler A. Assessment of adverse events in clinical drug trials: Identifying amitriptyline's placebo- and baseline-controlled side effects. Exp Clin Psychopharmacol. 2018 Jun;26(3):320-326. doi: 10.1037/pha0000194. PubMed 29863388 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02127736
Lead sponsor
Winfried Rief
Responsible party
Winfried Rief (Prof. Dr. Winfried Rief, Philipps University Marburg) — Sponsor-investigator
First posted
May 1, 2014
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Sep 3, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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