The Influence of Amitriptyline on Learning in a Visual Discrimination Task

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Amitriptyline; Drug: Placebo

• Registration Number: NCT01566825
• Lead Sponsor: Dieter Kunz, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-29
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amitriptyline	Amitriptyline	-
white 8 mm Lichtenstein®	Placebo	-

Primary Outcome Measures

Name	Time	Method
changes in the visual discrimination task's perception threshold	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 Outcome Measures

Name	Time	Method
amount of rapid eye movement (REM) sleep (sleep period time percentage)	night from day 10 to day 11

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Department of Physiology CBF; 🇩🇪 Berlin, Germany