Healthy ParticipantsNCT02127736
Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
A study testing Amitriptyline in people with Healthy Participants, run by Winfried Rief at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Amitriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento Sep 2014
- 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 69 years
- All sexes
- Adult, Older adult
Who may be able to join
- age between 18 years to 69 years
- willingness to refrain from alcohol consumption throughout the study
- regular sleeping habits
- fluent in German language
- is not dependent on driving to get to the study center
- provide written informed consent
- ability to understand the explanations and instructions given by the study physician and the investigator
Who cannot join
- Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history
- allergies to amitriptyline hydrochloride or any of its ingredients
- acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
- urinary retention
- delirium
- untreated closed-angle glaucoma
Show all 24Show fewer
- prostatic hyperplasia
- pyloric stenosis
- paralytic ileus
- suicidal thoughts
- liver/ kidney/ pulmonary insufficiency
- myasthenia gravis
- hypokalemia
- bradycardia
- coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
- increased risk of seizures/ history of seizures
- substance dependence syndrome/ history of substance dependence syndrome
- Allergies to ingredients of placebo or novel-tasting drink (CS)
- currently pregnant (verified by urine pregnancy test) or lactating
- patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)
- patients suffering from a medical condition (assessed by the study physician)
- Concomitant medication interfering with study medication intake due to potential interactions
- participation in any other clinical trial 3 months prior to visit 1
- employee of the Sponsor or the principal investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032
About this study
The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Amitriptyline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Amitriptyline; Drug: Placebo |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Total Sleep Time
assessed by polysomnography
Measured: 5 nights during the study
Percentage of rapid eye movement (REM) sleep
assessed by polysomnography
Measured: 5 nights during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Primary completionSep 2014
- Study completionSep 2014
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 ParticipantsStudies 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
Sponsor and investigators
- Lead sponsor
- Winfried Rief
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Winfried Rief, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127736
- Sponsor's protocol ID
- PSG40
- Status last verified
- Sep 2014
- First submitted
- 29 Apr 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
Publications
Rheker J, Rief W, Doering BK, Winkler A. Assessment of adverse events in clinical drug trials: Identifying amitriptyline's placebo- and baseline-controlled side effects. Exp Clin Psychopharmacol. 2018 Jun;26(3):320-326. doi: 10.1037/pha0000194.
PubMed 29863388
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
- ClinicalTrials.gov ID
- NCT02127736
- Acronym / sponsor ID
- PSG40
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Winfried RiefUniversity, hospital or other
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 May 2014 (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 evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Amitriptyline, Drug: Placebo |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 18 years to 69 years
- willingness to refrain from alcohol consumption throughout the study
- regular sleeping habits
- fluent in German language
- is not dependent on driving to get to the study center
Key exclusion criteria (24 listed)
- Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history
- Allergies to ingredients of placebo or novel-tasting drink (CS)
- currently pregnant (verified by urine pregnancy test) or lactating
- patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)
- patients suffering from a medical condition (assessed by the study physician)
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 |
|---|---|---|
| Amitriptyline | Drug | Experimental group |
| Placebo | Drug | Control group, Experimental group |
Primary outcome
Objective Total Sleep Time
Time frame: 5 nights during the study
assessed by polysomnography
Percentage of rapid eye movement (REM) sleep
Time frame: 5 nights during the study
assessed by polysomnography
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 3 Sep 2014.
- Derived from this study: PubMed 29863388Rheker J, Rief W, Doering BK, Winkler A. Assessment of adverse events in clinical drug trials: Identifying amitriptyline's placebo- and baseline-controlled side effects. Exp Clin Psychopharmacol. 2018 Jun;26(3):320-326. doi: 10.1037/pha0000194.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Participants, run by Winfried Rief 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 7 inclusion and 24 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 3 Sep 2014. 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?
Objective Total Sleep Time (time frame: 5 nights during the study). The study lists 2 primary outcomes in all. 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 NCT02127736, 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 3 Sep 2014.