Post Traumatic Stress DisordersNCT00893568
Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
A study testing resonance magnetic imaging (fMRI), in people with Post Traumatic Stress Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorders
- What is being tested?
- resonance magnetic imaging (fMRI),
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to May 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- French speakers
- Not hospitalized grown-up patients suffering from a post-traumatic stress disorder ( PTSD) connected to one event.
- Subjects Controls: grown-up, mated with the patients in age (18 - 50 years; 4 years maximum of difference of age between a patient and his control), in sex and educational level (schooling of the 3rd level, at the level Bac+8; 3 years maximum of difference of educational level between a patient and his control)
Who cannot join
- Pregnancy
- Feeding
- Nobody under guardianship and grown-up persons being the object of a legal protective measure or not able to express their assent
- Alcoholic or addicted to drugs (including medicines)
- Other neurological disorders or psychiatric that post-traumatic stress disorder (for patients)
- Claustrophobia and contraindications in the IRMf
Show all 9Show fewer
- Subjects controls, no known psychiatric or neurological pathology, as well as no psychiatric history.
- Persons private of freedom by a court or administrative order, persons hospitalized without assent
- Unability to read French
Trial locations and contacts
1 site in 1 country.
About this study
The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.
- Conditions
- Post Traumatic Stress Disorders
- Being tested
- resonance magnetic imaging (fMRI),
- Keywords
- Post traumatic stress disorder PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resonance magnetic imaging (fMRI),Other
a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Healthy volunteers without treatment Receives: Other: resonance magnetic imaging (fMRI), |
| CBT | Experimental | Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT) Receives: Other: resonance magnetic imaging (fMRI), |
| EMDR | Experimental | Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR) Receives: Other: resonance magnetic imaging (fMRI), |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD
Measured: 3 years
Secondary outcomes (1)
Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893568
- Sponsor's protocol ID
- 2009/01
- Other IDs
- 2009-A00193-54
- Status last verified
- Aug 2014
- First submitted
- 5 May 2009
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
- ClinicalTrials.gov ID
- NCT00893568
- Acronym / sponsor ID
- 2009/01
- Conditions
- Post Traumatic Stress Disorders
- Keywords
- Post traumatic stress disorder PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- First posted
- 6 May 2009 (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 post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Other: resonance magnetic imaging (fMRI),Healthy volunteers without treatment |
| CBT | Experimental | Other: resonance magnetic imaging (fMRI),Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT) |
| EMDR | Experimental | Other: resonance magnetic imaging (fMRI),Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- French speakers
- Not hospitalized grown-up patients suffering from a post-traumatic stress disorder ( PTSD) connected to one event.
- Subjects Controls: grown-up, mated with the patients in age (18 - 50 years; 4 years maximum of difference of age between a patient and his control), in sex and educational level (schooling of the 3rd level, at the level Bac+8; 3 years maximum of difference of educational level between a patient and his control)
Key exclusion criteria (9 listed)
- Pregnancy
- Feeding
- Nobody under guardianship and grown-up persons being the object of a legal protective measure or not able to express their assent
- Alcoholic or addicted to drugs (including medicines)
- Other neurological disorders or psychiatric that post-traumatic stress disorder (for patients)
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 |
|---|---|---|
| resonance magnetic imaging (fMRI),a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment) | Other | CBT, EMDR, Healthy volunteers |
Primary outcome
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD
Time frame: 3 years
1 secondary outcome
Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR
Time frame: 3 years
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 28 Aug 2014.
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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 resonance magnetic imaging (fMRI), in people with Post Traumatic Stress Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 9 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 28 Aug 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 France. 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?
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD (time frame: 3 years). 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 28 Aug 2014.