The Influence of Amitriptyline on Learning in a Visual Discrimination Task
1 other identifier
interventional
32
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedMarch 29, 2012
March 1, 2012
9 months
March 27, 2012
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (1)
amount of rapid eye movement (REM) sleep (sleep period time percentage)
night from day 10 to day 11
Study Arms (2)
Amitriptyline
ACTIVE COMPARATORwhite 8 mm Lichtenstein®
PLACEBO COMPARATORInterventions
amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11
Eligibility Criteria
You may qualify if:
- male gender
- age 18 through 40 years
- ability to communicate effectively in German
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dieter Kunz, MDlead
Study Sites (1)
Charité - Universitätsmedizin Berlin, Department of Physiology CBF
Berlin, 10115, Germany
Related Publications (1)
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.
PMID: 24790277DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dieter Kunz, MD
Charite University, Berlin, Germany
- PRINCIPAL INVESTIGATOR
Dieter Kunz, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Research Group Sleep Research and Clinical Chronobiology, Department of Physiology CBF, Charité - Universitätsmedizin Berlin
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
August 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 29, 2012
Record last verified: 2012-03