The Influence of Amitriptyline on Learning in a Visual Discrimination Task

March 27, 2012 updated by: Dieter Kunz, MD

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Charité - Universitätsmedizin Berlin, Department of Physiology CBF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amitriptyline
Drug: Amitriptyline
amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
Other Names:
  • Saroten
Placebo Comparator: white 8 mm Lichtenstein®
Drug: Placebo
placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dieter Kunz, MD

Investigators

  • Study Chair: Dieter Kunz, MD, Charite University, Berlin, Germany
  • Principal Investigator: Dieter Kunz, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVDT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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