The Influence of Amitriptyline on Learning in a Visual Discrimination Task

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566825
• Other study ID #: AVDT
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: March 27, 2012
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Amitriptyline
amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
• Placebo
placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Department of Physiology CBF	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Dieter Kunz, MD

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	amount of rapid eye movement (REM) sleep (sleep period time percentage)		night from day 10 to day 11	No