Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-04-20 @ 4:00 PM
Study NCT ID:
NCT02231268
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess a 6-months Treatment With Gladem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 546}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Scale (HAMD-6)', 'timeFrame': '3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'Global assessment of efficacy on a 4-point scale', 'timeFrame': 'up to 6 months'}, {'measure': 'Global assessment of compliance on a 4-point scale', 'timeFrame': 'up to 6 months'}, {'measure': 'Global assessment of tolerability on a 4-point scale', 'timeFrame': 'up to 6 months'}, {'measure': 'Clinical global impression score', 'timeFrame': 'up to 6 months'}, {'measure': 'Number of responders', 'timeFrame': 'up to 6 months', 'description': '\\>= 50 % reduction in HAMD-6 score'}, {'measure': 'Change in HAMD subscores', 'timeFrame': 'baseline, 6 months'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 6 months'}]}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': '* Evaluation of a 6-months treatment with Gladem\n* Experiences with the internet for performing a postmarketing study (PMS) trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'studyPopulation': 'out-patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women at least 18 years old\n* De novo prescription of Gladem\n* Treatment with Gladem intended for at least 6 months\n* Depressive disorders\n\nExclusion Criteria:\n\n* Known hypersensitivity against sertraline\n* Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)\n* Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine\n* Instable epilepsy\n\nAccording to product information (October 1998) Gladem prescription was possible with precautions in the following cases:\n\n* Patients with stable epilepsy\n* Patients with restricted liver functions\n* Suicidal patients\n* Patients in emotional state and marked sleeping disorders\n\nAccording to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.'}, 'identificationModule': {'nctId': 'NCT02231268', 'briefTitle': 'Observational Study to Assess a 6-months Treatment With Gladem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Study Via Internet to Assess a 6-months Treatment With GLADEM', 'orgStudyIdInfo': {'id': '533.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depressive patients', 'interventionNames': ['Drug: Gladem']}], 'interventions': [{'name': 'Gladem', 'type': 'DRUG', 'armGroupLabels': ['Depressive patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}