The Influence of Amitriptyline on Learning in a Visual Discrimination Task
This study has been completed.
Sponsor:
Dieter Kunz, MD
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
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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
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
| 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 May 19, 2013