Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT00912535
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2009-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2009-05-24', 'studyFirstSubmitQcDate': '2009-05-31', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Anxiety Scale(HAMA-A) total score', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}], 'secondaryOutcomes': [{'measure': 'Item scores for Abnormal Involuntary Movement Scale(AIMS)', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}, {'measure': 'Item scores of Barnes-Akathisia Rating Scale (BARS)', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}, {'measure': 'Item scores of Simpson-Angus Scale(SAS)', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}, {'measure': 'Body Weight', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}, {'measure': 'Vital signs', 'timeFrame': '2 months', 'description': 'From baseline to Week 1, Week 4 and Week 8'}, {'measure': 'Adverse event/Serious adverse event', 'timeFrame': '8-9 weeks', 'description': 'From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8'}]}, 'conditionsModule': {'keywords': ['Primary Anxiety Disorders', 'Mood Disorders with Comorbid Anxiety Symptoms'], 'conditions': ['Primary Anxiety Disorders', 'Mood Disorders With Comorbid Anxiety Symptoms']}, 'referencesModule': {'references': [{'pmid': '23020711', 'type': 'DERIVED', 'citation': 'Chen YC, Chen CK, Wang LJ. Quetiapine fumarate augmentation for patients with a primary anxiety disorder or a mood disorder: a pilot study. BMC Psychiatry. 2012 Sep 29;12:162. doi: 10.1186/1471-244X-12-162.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent\n* A diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)\n* A 14-item Hamilton Anxiety Scale (HAM-A)\\>= 14\n* Subject have received single antidepressant at a therapeutic dose for at least 6 weeks\n* Male or female aged 18-65 years\n* Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment\n* Able to understand and comply with the requirements of the study and sign informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Any DSM-IV Axis I disorder not defined in the inclusion criteria.\n* Receiving any anti-psychotic 7 days prior to entering the study\n* Patients who, in the opinion of the investigator, post an imminent risk of suicide or a danger to self or others\n* Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator\n* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir\n* Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St.John's Wort, and glucocorticoids\n* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization\n* Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria\n* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment\n* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment\n* Unstable or inadequately treated medical illness (e.g. congestive heart failures, angina pectoris, hypertension) as judged by the investigator\n* Involvement in the planning and conduct of the study\n* Previous enrollment or randomization of treatment in the present study\n* Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements\n* A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:\n\n * Unstable DM defined as enrollment glycosylated hemoglobin(HbA1c)\\> 8.5%\n * Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.\n * Not under physician care for DM\n * Physician responsible for patient's DM care has not indicated that patient's DM is controlled\n * Physician responsible for patient's DM care has not approved patient's participation in the study\n * Has not been on the same dose of oral hypoglycaemic drug(S) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones(glitazones) this period should not be less than 8 weeks\n * Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks\n* An absolute neutrophil count (ANC) of \\<= 1.5x10(9) per liter"}, 'identificationModule': {'nctId': 'NCT00912535', 'briefTitle': 'Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms', 'orgStudyIdInfo': {'id': 'D1443C00026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quetiapine extended release tablet', 'description': 'Quetiapine orally at a flexible dose fo 50-300mg/day according to the judgment by the investigator for 8 weeks, as adjunct to the same antidepressant at the same dose.', 'interventionNames': ['Drug: Quetiapine extended release tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo orally, as adjunct to the same antidepressant at the same dose.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Quetiapine extended release tablet', 'type': 'DRUG', 'description': 'Quetiapine extended release tablet of 50-300mg/day', 'armGroupLabels': ['Quetiapine extended release tablet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo orally, as adjunct to the same antidepressant at the same dose.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Keelung', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Keelung', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}], 'overallOfficials': [{'name': 'Chih-Ken Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Chih-Ken Chen', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}