Impact of escitalopram on nocturnal sleep, daytime sleepiness and performance compared to amitriptyline: A randomized, double-blind, placebo-controlled study in healthy male subjects.
- Conditions
- healthy subjects
- Registration Number
- DRKS00000160
- Lead Sponsor
- niversitätsklinikum Freiburg Abteilung für Psychiatrie und PsychotherapieSchlaflabor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 14
Healthy male subjects, 20-32years old.
-School education for at least 13 years (Abitur)
-IQ (Raven) at least 90
-Keeping a sleep diary for 5 days before the first polysomnography night
-Any current physical disorder, which can influence sleep
-Any chronic physical disorder, which can influence sleep
-Any relevant internal or neurological disorder
-Increased intraocular pressure
-Former epileptic seizures
-Gastro-interstinal disturbances, which could influence medication resorption
-Endocrine disturbances
-Current or former mental disorder classified in the ICD-10 or DSMIV
-Any intake of sleeping pills or other psychotropic drugs
-Drug or Substance abuse or addiction
-Any participation in another clinical trial in the last 30 days
-Insufficient knowledge of german language
-Currently or former sleep disorders or high daytime sleepiness
-Shift working
-Unstable sleeping habits
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method influence of 10 mg escitalopram, 75 mg amitriptyline and placebo on:<br>-REM sleep (REM latencyin min. and %)<br>-sleep continuity<br>-daytime sleepiness meassured by MSLT
- Secondary Outcome Measures
Name Time Method daytime performance<br>periodic limb movements<br>neuroendocrinology