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Completed

NCT Number: NCT01566825

The Influence of Amitriptyline on Learning in a Visual Discrimination Task

The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep dependent consolidation of procedural memory (visual discrimination task, Karni-Sagi-paradigm).

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Key information

Conditions

Healthy Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin, Department of Physiology CBF

Berlin, 10115, Germany

About this study

Rapid eye movement (REM) sleep is considered critical to the consolidation of procedural memory - the memory of skills and habits. Many antidepressants strongly suppress REM sleep, however, and procedural memory consolidation has been shown to be impaired in depressed patients on antidepressant therapy. As a result, it is important to determine whether antidepressive therapy can lead to amnestic impairment. We thus investigate the effects of the anticholinergic antidepressant amitriptyline on sleep-dependent memory consolidation in 32 healthy men in a double-blind, placebo-controlled, randomized parallel-group study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male gender
  • age 18 through 40 years
  • ability to communicate effectively in German

Exclusion criteria

  • shift work within the past 24 months
  • any sleep disorder as measured by the Pittsburgh Sleep Quality Index
  • irregular sleep/wake patterns or extreme chronotype as measured by the Morningness-Eveningness Questionnaire
  • history of any neurologic or psychiatric disorders
  • regular medication intake within the past four weeks
  • contraindications for amitriptyline
  • abnormal electrocardiogram (ECG)

Treatment and study plan

Amitriptyline

Drug

amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11

Other names: Saroten

Placebo

Drug

placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11

Primary outcomes

  1. changes in the visual discrimination task's perception threshold

    Time frame: The visual discrimination task's perception treshold is assessed before sleep (day 10 at 6 pm) and after sleep (day 11 at 6 pm).

    Improvement in this task is defined as a decrease in the perception threshold between training and retrieval testing.

Secondary outcomes

  1. amount of rapid eye movement (REM) sleep (sleep period time percentage)

    Time frame: night from day 10 to day 11

Sponsors and collaborators

Lead sponsor

Dieter Kunz, MD

Other

Registry information

Official study title

The Influence of Amitriptyline (Amitriptylin-CT 25 mg®) on Learning in a Visual Discrimination Task (Karni-Sagi-paradigm)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 29, 2012
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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