Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 3, 2014
September 1, 2014
April 29, 2014
September 1, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Total Sleep Time
assessed by polysomnography
5 nights during the study
Percentage of rapid eye movement (REM) sleep
assessed by polysomnography
5 nights during the study
Study Arms (2)
Experimental group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Winfried Rieflead
Study Sites (1)
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032, Germany
Related Publications (1)
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.
PMID: 29863388DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Winfried Rief
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 3, 2014
Record last verified: 2014-09