Healthy Subjects Clinical Trial
Official title:
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).
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin, Department of Physiology CBF | Berlin |
Lead Sponsor | Collaborator |
---|---|
Dieter Kunz, MD |
Germany,
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 |
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