Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-05 @ 6:01 AM
Study NCT ID:
NCT01664260
Status:
WITHDRAWN
Last Update Posted:
2018-02-09
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The research project has been cancelled before any participants were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-10', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach', 'timeFrame': 'Baseline, 8th weeks'}, {'measure': 'Change from baseline in Clinician-administered PTSD scale scores at 4th weeks', 'timeFrame': 'Baseline, 4th weeks'}, {'measure': 'Change from baseline in Clinician-administered PTSD scale scores at 8th weeks', 'timeFrame': 'Baseline, 8th weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Hamilton depression rating scale scores at 4th weeks', 'timeFrame': 'Baseline, 4th weeks'}, {'measure': 'Change from baseline in Hamilton depression rating scale scores at 8th weeks', 'timeFrame': 'Baseline, 8th weeks'}, {'measure': 'Change from baseline in Hamilton anxiety rating scale scores at 4th weeks', 'timeFrame': 'Baseline, 4th weeks'}, {'measure': 'Change from baseline in Hamilton anxiety rating scale scores at 8th weeks', 'timeFrame': 'Baseline, 8th weeks'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '4th weeks'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '8th weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Posttraumatic Stress Disorder', 'N-acetylcysteine', 'Magnetic Resonance Imaging'], 'conditions': ['Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will induce change in structural, functional, and neurochemical aspects of the brain.\n\nIn this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and safety of the N-acetylcysteine augmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-65 year-old male or female\n* Posttraumatic stress disorder diagnosed by SCID-IV\n* Written informed consent\n\nExclusion Criteria:\n\n* Medication treatment for posttraumatic stress disorder within 2 weeks\n* Neurologic disease (eg., penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, cerebrovascular diseases)\n* Any other axis I psychiatric disorder\n* IQ below 80\n* Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.)\n* Any psychotropic medication within 2 weeks\n* Unstable medical illness or severe abnormality in laboratory test at screening assessment\n* Women who are pregnant, breastfeeding, or planning pregnancy\n* History of myocardial infarction within 6 months\n* Current diagnosis of duodenal ulcer or asthma\n* Contraindications to drugs used in the study (e.g., epilepsy, uncontrolled narrow-angle glaucoma, etc.)\n* Allergy or intolerance to the study drug'}, 'identificationModule': {'nctId': 'NCT01664260', 'briefTitle': 'Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study', 'orgStudyIdInfo': {'id': 'iklnac'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-acetylcysteine + Escitalopram', 'description': 'The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Escitalopram', 'description': 'The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': '0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day', 'armGroupLabels': ['N-acetylcysteine + Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day', 'armGroupLabels': ['Placebo + Escitalopram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Inkyoon Lyoo, MD, PhD, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'In Kyoon Lyoo', 'investigatorAffiliation': 'Ewha Womans University'}}}}