Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-06-08 @ 3:26 PM
Study NCT ID:
NCT03780595
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Passiflora Extract for Benzodiazepine Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose', 'timeFrame': '10 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzodiazepine', 'Withdrawal', 'passiflora'], 'conditions': ['Benzodiazepine Withdrawal (Disorder)']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 65 years old\n2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)\n3. Capable of giving consent and to answer the questionnaires according to researcher criteria\n\nExclusion Criteria:\n\n1. Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).\n2. Acute confusional syndrome at the inclusion\n3. Panic disorder\n4. Obsesive-compulsive disorder\n5. Any type of psycosis or bipolar disorder\n6. Severe Parkison disease diagnosed\n7. Current or past diagnosis of epilepsia\n8. Recent stroke (last month)\n9. Thyroid disorders not controlled or uncompensated\n10. Alteration of deglutition\n11. Previous drugs or alcohol abuse\n12. Hospitalization (more than 24 hours) during the last month\n13. Complex priority treatment (dialisis, chemotherapy...)\n14. Life expectation less than 1 year\n15. Benzodiazepines therapeutic uses not for anxiety or insomnio'}, 'identificationModule': {'nctId': 'NCT03780595', 'acronym': 'SEDISTRESS', 'briefTitle': 'Passiflora Extract for Benzodiazepine Withdrawal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricion Medica S.L.'}, 'officialTitle': 'Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III', 'orgStudyIdInfo': {'id': 'SEDISTRESS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Passiflora', 'interventionNames': ['Drug: Passiflora incarnata']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Passiflora incarnata', 'type': 'DRUG', 'description': 'Passiflora pills administration up to 6 pills per day', 'armGroupLabels': ['Passiflora']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Control pills administration up to 6 pills per day', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Macarena Maroto Algarra, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Albertia Moratalaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carmen Figueroa Linki, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Amavir Ciudad Lineal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Mallón Redondo, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Nogales Imperial', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carmela Mañas Martínez, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Nogales Pontones', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Adriá León García, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Nogales Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Majadahonda', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Liliana González Espinosa, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Albertia Valle de la Oliva', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'San Agustín del Guadalix', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Luis Cañón, MD', 'role': 'CONTACT'}], 'facility': 'Residencia Amavir San Agustín', 'geoPoint': {'lat': 40.67882, 'lon': -3.61639}}, {'city': 'Torrejón de Ardoz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sara González Blazquez, MD', 'role': 'CONTACT'}, {'name': 'May Ling Carmiña Rodríguez, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Residencia Amavir Torrejón', 'geoPoint': {'lat': 40.45535, 'lon': -3.46973}}], 'centralContacts': [{'name': 'María de Andres', 'role': 'CONTACT', 'email': 'mariade.andres@nutricionmedica.com', 'phone': '+34 913 14 92 71'}], 'overallOfficials': [{'name': 'Luis Fernando Agüera', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricion Medica S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}