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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

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Amitriptyline Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Official Title: Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group Drug: Amitriptyline
Drug: Placebo
Placebo Comparator: Control group Drug: Placebo



Primary Outcome Measures :
  1. Objective Total Sleep Time [ Time Frame: 5 nights during the study ]
    assessed by polysomnography

  2. Percentage of rapid eye movement (REM) sleep [ Time Frame: 5 nights during the study ]
    assessed by polysomnography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127736


Locations
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Germany
Department of Psychology, Philipps University Marburg
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Winfried Rief

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Winfried Rief, Prof. Dr. Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT02127736     History of Changes
Other Study ID Numbers: PSG40
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants