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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amitriptyline | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion 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 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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, Philipps University Marburg | Marburg | Hesse | 35032 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29863388 | Derived | 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. |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |