Intrusive MemoriesNCT02541071
Influence of the Noradrenergic System on the Formation of Intrusive Memories
A study testing Stress Film, Yohimbine and Clonidine in people with Intrusive Memories, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories
- What is being tested?
- Stress Film, Yohimbine and Clonidine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Oct 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants
- German on a native level
Who cannot join
- former or present DSM IV Axis I disorders
- physical illnesses
- any medication intake (except oral contraceptive)
- history of sexual abuse or rape
- pregnancy or lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Charité University Medicine Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, 12203
About this study
Official title: Influence of the Noradrenergic System on the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.
Read the detailed description
The investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.
- Conditions
- Intrusive Memories
- Being tested
- Stress Film, Yohimbine, Clonidine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress FilmBehavioural
YohimbineDrug
ClonidineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Yohimbine and Stress Film | Experimental | Administration of 10mg yohimbine before the trauma film. Receives: Behavioral: Stress Film; Drug: Yohimbine |
| Placebo and Stress Film | Experimental | Administration of placebo before the trauma film. Receives: Behavioral: Stress Film; Drug: placebo |
| Clonidine and Stress Film | Experimental | Administration of 0.15mg clonidine before the trauma film. Receives: Behavioral: Stress Film; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusive memories
Measured with an intrusion diary
Measured: four consecutive days
Secondary outcomes (2)
Vividness of intrusive memories
Measured with an intrusion diary
Measured: four consecutive days
Degree of distress of intrusive memories
Measured with an intrusion diary
Measured: four consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive MemoriesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dipl.- Psych. Felicitas Rombold, Charite University, Berlin, Germany
- Investigators
- Stefan Roepke, Dr., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541071
- Sponsor's protocol ID
- Rombold_01
- Status last verified
- Sep 2015
- First submitted
- 6 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Noradrenergic System on the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
- ClinicalTrials.gov ID
- NCT02541071
- Acronym / sponsor ID
- Rombold_01
- Conditions
- Intrusive Memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Sep 2015 (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.
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.
Detailed description
The investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yohimbine and Stress Film | Experimental | Behavioral: Stress Film, Drug: YohimbineAdministration of 10mg yohimbine before the trauma film. |
| Placebo and Stress Film | Experimental | Behavioral: Stress Film, Drug: placeboAdministration of placebo before the trauma film. |
| Clonidine and Stress Film | Experimental | Behavioral: Stress Film, Drug: ClonidineAdministration of 0.15mg clonidine before the trauma film. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy participants
- German on a native level
Key exclusion criteria (5 listed)
- former or present DSM IV Axis I disorders
- physical illnesses
- any medication intake (except oral contraceptive)
- history of sexual abuse or rape
- pregnancy or lactation period
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 |
|---|---|---|
| Stress Film | Behavioural | Clonidine and Stress Film, Placebo and Stress Film, Yohimbine and Stress Film |
| Yohimbine | Drug | Yohimbine and Stress Film |
| Clonidine | Drug | Clonidine and Stress Film |
| placebo | Drug | Placebo and Stress Film |
Primary outcome
Number of intrusive memories
Time frame: four consecutive days
Measured with an intrusion diary
2 secondary outcomes
Vividness of intrusive memories
Time frame: four consecutive days
Degree of distress of intrusive memories
Time frame: four consecutive days
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 4 Sep 2015.
Related trials for Intrusive Memories
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Tetris Intervention Following Subliminal Reactivation for Intrusive Memories
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A Digital Cognitive Intervention for Intrusive Memories After Trauma
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Exposure by Assessment: Effects of Daily AMQ-Based EMA of an Intrusive Trauma Memory in PTSD
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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.
Stefan Roepke, Dr. study director
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 Stress Film, Yohimbine and Clonidine in people with Intrusive Memories, run by Charite University, Berlin, Germany 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 2 inclusion and 5 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 4 Sep 2015. 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. 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?
Number of intrusive memories (time frame: four consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2015.