Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-27 @ 2:12 AM
Study NCT ID:
NCT00374166
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C456029', 'term': '1-(5-chloro-1-((2,4-dimethoxyphenyl)sulfonyl)-3-(2-methoxyphenyl)-2-oxo-2,3-dihydro-1H-indol-3-yl)-4-hydroxy-N,N-dimethyl-2-pyrrolidinecarboxamide'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-26', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2006-09-07', 'dispFirstSubmitQcDate': '2016-04-26', 'studyFirstSubmitQcDate': '2006-09-07', 'dispFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anti-anxiety agents', 'antidepressive agents', 'controlled clinical trial'], 'conditions': ['Anxiety Disorders']}, 'referencesModule': {'references': [{'pmid': '23146246', 'type': 'DERIVED', 'citation': 'Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of generalized anxiety disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module.\n\nExclusion Criteria:\n\n* Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A.\n* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17.\n* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.\n* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.\n* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine oxidase inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.\n\nThe investigator will evaluate whether there are other reasons why a patient may not participate.'}, 'identificationModule': {'nctId': 'NCT00374166', 'briefTitle': 'An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'DFI5880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSR149415 - 250 mg', 'description': 'SSR149415 250 mg, twice daily for a maximum of 8 weeks', 'interventionNames': ['Drug: SSR149415']}, {'type': 'EXPERIMENTAL', 'label': 'SSR149415 - 100 mg', 'description': 'SSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks', 'interventionNames': ['Drug: SSR149415', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paroxetine', 'description': 'Paroxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks', 'interventionNames': ['Drug: Placebo', 'Drug: Paroxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for a maximum of 9 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SSR149415', 'type': 'DRUG', 'description': 'Oral administration (capsules of 50 and 100 mg)', 'armGroupLabels': ['SSR149415 - 100 mg', 'SSR149415 - 250 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration (capsules)', 'armGroupLabels': ['Paroxetine', 'Placebo', 'SSR149415 - 100 mg']}, {'name': 'Paroxetine', 'type': 'DRUG', 'description': 'Oral administration (capsules)', 'armGroupLabels': ['Paroxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}