The Influence of Amitriptyline on Learning in a Visual Discrimination Task

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dieter Kunz, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01566825
First received: March 27, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 27, 2012
March 27, 2012
August 2008
May 2009   (final data collection date for primary outcome measure)
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). ] [ Designated as safety issue: No ]
Improvement in this task is defined as a decrease in the perception threshold between training and retrieval testing.
Same as current
No Changes Posted
amount of rapid eye movement (REM) sleep (sleep period time percentage) [ Time Frame: night from day 10 to day 11 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Influence of Amitriptyline on Learning in a Visual Discrimination Task
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Healthy Subjects
  • Drug: Amitriptyline
    amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
    Other Name: Saroten
  • Drug: Placebo
    placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11
  • Active Comparator: Amitriptyline
    Intervention: Drug: Amitriptyline
  • Placebo Comparator: white 8 mm Lichtenstein®
    Intervention: Drug: Placebo
Goerke M, Cohrs S, Rodenbeck A, Kunz D. Differential effect of an anticholinergic antidepressant on sleep-dependent memory consolidation. Sleep. 2014 May 1;37(5):977-85. doi: 10.5665/sleep.3674.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2009
May 2009   (final data collection date for primary outcome measure)

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)
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01566825
AVDT
Yes
Dieter Kunz, MD, Charite University, Berlin, Germany
Dieter Kunz, MD
Not Provided
Study Chair: Dieter Kunz, MD Charite University, Berlin, Germany
Principal Investigator: Dieter Kunz, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP