Healthy SubjectsNCT01566825
The Influence of Amitriptyline on Learning in a Visual Discrimination Task
A study testing Amitriptyline in people with Healthy Subjects, run by Dieter Kunz, MD at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Amitriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male gender
- age 18 through 40 years
- ability to communicate effectively in German
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin, Department of Physiology CBF
Berlin, 10115
About this study
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).
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Amitriptyline, Placebo
- Keywords
- amitriptyline, sleep dependent memory consolidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Saroten
amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
PlaceboDrug
placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Active comparator | Not described Receives: Drug: Amitriptyline |
| white 8 mm Lichtenstein® | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: night from day 10 to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dieter Kunz, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dieter Kunz, MD, Charite University, Berlin, Germany
- Investigators
- Dieter Kunz, MD, Study chair, Charite University, Berlin, GermanyDieter Kunz, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566825
- Sponsor's protocol ID
- AVDT
- Status last verified
- Mar 2012
- First submitted
- 27 Mar 2012
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24790277
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Amitriptyline (Amitriptylin-CT 25 mg®) on Learning in a Visual Discrimination Task (Karni-Sagi-paradigm)
- ClinicalTrials.gov ID
- NCT01566825
- Acronym / sponsor ID
- AVDT
- Conditions
- Healthy Subjects
- Keywords
- amitriptyline, sleep dependent memory consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dieter Kunz, MDUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Active comparator | Drug: Amitriptyline |
| white 8 mm Lichtenstein® | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male gender
- age 18 through 40 years
- ability to communicate effectively in German
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAlso: Sarotenamitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11 | Drug | Amitriptyline |
| Placeboplacebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11 | Drug | white 8 mm Lichtenstein® |
Primary outcome
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).
Improvement in this task is defined as a decrease in the perception threshold between training and retrieval testing.
1 secondary outcome
amount of rapid eye movement (REM) sleep (sleep period time percentage)
Time frame: night from day 10 to day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
- Derived from this study: PubMed 24790277Goerke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Kunz, MD study chair
Charite University, Berlin, Germany
Dieter Kunz, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline in people with Healthy Subjects, run by Dieter Kunz, MD at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.