Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-27 @ 12:14 PM
Study NCT ID:
NCT00893568
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2009-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003130', 'term': 'Combat Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post traumatic stress disorder PTSD'], 'conditions': ['Post Traumatic Stress Disorders']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* French speakers\n* Not hospitalized grown-up patients suffering from a post-traumatic stress disorder ( PTSD) connected to one event.\n* 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)\n\nExclusion Criteria:\n\n* Pregnancy\n* Feeding\n* Nobody under guardianship and grown-up persons being the object of a legal protective measure or not able to express their assent\n* Alcoholic or addicted to drugs (including medicines)\n* Other neurological disorders or psychiatric that post-traumatic stress disorder (for patients)\n* Claustrophobia and contraindications in the IRMf\n* Subjects controls, no known psychiatric or neurological pathology, as well as no psychiatric history.\n* Persons private of freedom by a court or administrative order, persons hospitalized without assent\n* Unability to read French'}, 'identificationModule': {'nctId': 'NCT00893568', 'briefTitle': 'Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment', 'orgStudyIdInfo': {'id': '2009/01'}, 'secondaryIdInfos': [{'id': '2009-A00193-54'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'description': 'Healthy volunteers without treatment', 'interventionNames': ['Other: resonance magnetic imaging (fMRI),']}, {'type': 'EXPERIMENTAL', 'label': 'CBT', 'description': 'Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)', 'interventionNames': ['Other: resonance magnetic imaging (fMRI),']}, {'type': 'EXPERIMENTAL', 'label': 'EMDR', 'description': 'Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)', 'interventionNames': ['Other: resonance magnetic imaging (fMRI),']}], 'interventions': [{'name': 'resonance magnetic imaging (fMRI),', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['CBT', 'EMDR', 'Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique-Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}