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
  Purpose

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).


Condition Intervention
Healthy Subjects
Drug: Amitriptyline
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: The Influence of Amitriptyline (Amitriptylin-CT 25 mg®) on Learning in a Visual Discrimination Task (Karni-Sagi-paradigm)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amitriptyline Drug: Amitriptyline
amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01566825

Locations
Germany
Charité - Universitätsmedizin Berlin, Department of Physiology CBF
Berlin, Germany, 10115
Sponsors and Collaborators
Dieter Kunz, MD
Investigators
Study Chair: Dieter Kunz, MD Charite University, Berlin, Germany
Principal Investigator: Dieter Kunz, MD Charite University, Berlin, Germany
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dieter Kunz, MD, Director of the Research Group Sleep Research and Clinical Chronobiology, Department of Physiology CBF, Charité - Universitätsmedizin Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01566825     History of Changes
Other Study ID Numbers: AVDT
Study First Received: March 27, 2012
Last Updated: March 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
amitriptyline
sleep dependent memory consolidation

Additional relevant MeSH terms:
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 28, 2014