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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000160

Enrollment

Registered

2009-07-23

Start date

2006-10-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Group 1: 10 mg Escitalopram in 10 healthy subjects double-blind, crossover Group 2: 75 mg Amitriptylin in 10 healthy subjects double-blind, crossover Group 3: Placebo in 10 healthy subjects double-

Eligibility

Sex/Gender

Male

Age

20 Years to 32 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
daytime performance periodic limb movements neuroendocrinology	—

Countries

Germany

Contacts

Public ContactJohn-Peter Doerr

Universitätsklinikum Freiburg Klinik für Psychiatrie Abt. Psychiatrie und Psychotherapie

John-Peter.doerr@uniklinik-freiburg.de0761/270-6581

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026