Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-01 @ 9:06 AM
Study NCT ID:
NCT01046851
Status:
UNKNOWN
Last Update Posted:
2012-01-04
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nopan Treatment of Acute Suicidality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-31', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Suicidality as expressed by the score on the BSI', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in depression as measured by the BDI', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Suicidality']}, 'descriptionModule': {'briefSummary': 'Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suicidal behavior or ideation (BSI\\>6)\n\nExclusion Criteria:\n\n* ECT history within the last month\n* psychotic features within the last 3 months\n* history of schizophrenia, substance or alcohol abuse within the last two years\n* benzodiazepine dependence within the last two years\n* any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician\n* pregnant women\n* patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.'}, 'identificationModule': {'nctId': 'NCT01046851', 'briefTitle': 'A Study of Nopan Treatment of Acute Suicidality', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality', 'orgStudyIdInfo': {'id': 'ISAN-001-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nopan', 'interventionNames': ['Drug: Nopan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nopan', 'type': 'DRUG', 'otherNames': ['Subotex'], 'description': 'Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)', 'armGroupLabels': ['Nopan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo in a manner similar to the active comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bat Yam', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gali Bar, MA', 'role': 'CONTACT', 'email': 'galibar@bezeqint.net'}, {'name': 'Mordechai Masiah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abarbanel MHC', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}, {'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gali Bar, MA', 'role': 'CONTACT', 'email': 'galibar@bezeqint.net'}, {'name': 'Jack Asherov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nathaniel Laor, MD, PhD, Director', 'role': 'CONTACT', 'phone': '972-3-5720808'}, {'name': 'Nathaniel Laor, MD, PhD, Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brill Community Mental Health Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Yoram Yovell, MD, PhD', 'role': 'CONTACT', 'email': 'isan@research.haifa.ac.il', 'phone': '972-4-8249910'}], 'overallOfficials': [{'name': 'Yoram Yovell, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Haifa, Institute for the Study of Affective Neuroscience'}, {'name': 'Mordechai Masiah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abarbanel MHC'}, {'name': 'Jack Asherov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Wolfson Medical Center'}, {'name': 'Nathaniel Laor, MD, PhD, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv- Brill Community Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Yoram Yovell', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Prof. Yoram Yovell', 'investigatorAffiliation': 'University of Haifa'}}}}