Trial document





This trial has been registered retrospectively.
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  DRKS00000160

Trial Description

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Title

Impact of escitalopram on nocturnal sleep, daytime sleepiness and performance compared to amitriptyline: A randomized, double-blind, placebo-controlled study in healthy male subjects.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study compares the effects of 2 antidepressants (Escitalopram and Amitriptyline) on sleep and daytime sleepiness with each other and vs. placebo in young and healthy adults. Everybody receives - double blind and randomized - placebo, amitriptyline and escitalopram once with weekly intervals. After a first night in sleep laboratory, which is planned to adapt to the sleeping conditions in laboratory, a second night is performed after medication intake 2 hours before lights off. In both nights (or in all 6 nights respectively) sleep parameters are measured by polysomnography. The following day daytime sleepiness is measured also by polysomnography. Every 2 hours subjects go to bed for 20 min (5 times during the day). Subjective Sleep quality is ask for by sleep questionaires. In the morning after the 2nd night different concentration and memory tasks are performed and blood samples are taken.

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Brief Summary in Scientific Language

We investigated the acute impact of 10 mg escitalopram (ESCIT), the s-enantiomer of citalopram, on polysomnographic sleep and daytime sleepiness in comparison to 75 mg amitriptyline (AMI) and placebo (PLAC) with a double-blind cross-over design. Sleep parameters were recorded by standard polysomnography including a multiple sleep latency test (MSLT). Healthy male subjects undergo 3 periods of 2 consecutive nights of polysomnography in the sleep laboratory separated by at least 7 days. After an adaptation night and 2 h before starting night-time recordings for the 2nd night either 10 mg ESCIT, 75 mg AMI or PLAC was administered double-blind (at 9 p.m.). On the following day MSLT was conducted. Each morning subjective sleep parameters were measured by sleep questionaire. After the 2nd night memory and performance tasks were presented in a standardized test battery and blood samples were taken after awakening.

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Organizational Data

  •   DRKS00000160
  •   2009/07/23
  •   2006/11/06
  •   yes
  •   Approved
  •   170/06, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   2006-001948-31 
  •   UKF000917  (Register Klinischer Studien des Universitätsklinikums Freiburg)
  •   4031995 
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Health Condition or Problem studied

  •   healthy subjects
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Interventions/Observational Groups

  •   10 mg Escitalopram in 10 healthy subjects

    double-blind, crossover
  •   75 mg Amitriptylin in 10 healthy subjects

    double-blind, crossover
  •   Placebo in 10 healthy subjects

    double-blind, crossover
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
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Primary Outcome

influence of 10 mg escitalopram, 75 mg amitriptyline and placebo on:
-REM sleep (REM latencyin min. and %)
-sleep continuity
-daytime sleepiness meassured by MSLT

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Secondary Outcome

daytime performance
periodic limb movements
neuroendocrinology

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2006/10/03
  •   14
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   20   Years
  •   32   Years
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Additional Inclusion Criteria

-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

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Exclusion Criteria

-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

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Addresses

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    • Universitätsklinikum Freiburg Abteilung für Psychiatrie und Psychotherapie Schlaflabor
    • Mr.  Prof. Dr. med.  Ulrich  Voderholzer 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. med.  Ulrich  Voderholzer 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Psychiatrie Abt. Psychiatrie und Psychotherapie
    • Mr.  Dr. med.  John-Peter  Doerr 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Lundbeck GmbH
    • Ms.  Dr.  Michaela  Siebert 
    • Karnapp 25
    • 21079  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/06/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.