The Influence of Amitriptyline on Learning in a Visual Discrimination Task

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Amitriptyline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amitriptyline<br> | Drug: Amitriptyline<br>* amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11<br>* Other names: Saroten;|
| Placebo Comparator: white 8 mm Lichtenstein®<br> | Drug: Placebo<br>* placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the visual discrimination task's perception threshold | Improvement in this task is defined as a decrease in the perception threshold between training and retrieval testing. | The visual discrimination task's perception treshold is assessed before sleep (day 10 at 6 pm) and after sleep (day 11 at 6 pm). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of rapid eye movement (REM) sleep (sleep period time percentage) |  | night from day 10 to day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amitriptyline, sleep dependent memory consolidation