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Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

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ClinicalTrials.gov Identifier: NCT02127736
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center

Tracking Information
First Submitted Date  ICMJE April 29, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April¬†29,¬†2014)
  • Objective Total Sleep Time [ Time Frame: 5 nights during the study ]
    assessed by polysomnography
  • Percentage of rapid eye movement (REM) sleep [ Time Frame: 5 nights during the study ]
    assessed by polysomnography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02127736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
Official Title  ICMJE Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Amitriptyline
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Experimental group
    Interventions:
    • Drug: Amitriptyline
    • Drug: Placebo
  • Placebo Comparator: Control group
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02127736
Other Study ID Numbers  ICMJE PSG40
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Winfried Rief, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Winfried Rief
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Philipps University Marburg Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP