Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT01109693
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategic Use of New Generation Antidepressants for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D000078785', 'term': 'Mirtazapine'}], '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'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observer-rated depression severity (PHQ-9)', 'timeFrame': '9 weeks', 'description': 'Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.'}], 'secondaryOutcomes': [{'measure': 'Self-rated depression severity (BDI-II)', 'timeFrame': '9 weeks', 'description': 'Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves.'}, {'measure': 'Global rating of side effects (FIBSER)', 'timeFrame': '9 weeks', 'description': 'FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Unipolar Major Depressive Episode']}, 'referencesModule': {'references': [{'pmid': '29991347', 'type': 'DERIVED', 'citation': 'Kato T, Furukawa TA, Mantani A, Kurata K, Kubouchi H, Hirota S, Sato H, Sugishita K, Chino B, Itoh K, Ikeda Y, Shinagawa Y, Kondo M, Okamoto Y, Fujita H, Suga M, Yasumoto S, Tsujino N, Inoue T, Fujise N, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M, Miki K, Ogawa Y, Takeshima N, Hayasaka Y, Tajika A, Shinohara K, Yonemoto N, Tanaka S, Zhou Q, Guyatt GH; SUN☺D Investigators. Optimising first- and second-line treatment strategies for untreated major depressive disorder - the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial. BMC Med. 2018 Jul 11;16(1):103. doi: 10.1186/s12916-018-1096-5.'}, {'pmid': '26466684', 'type': 'DERIVED', 'citation': 'Yonemoto N, Tanaka S, Furukawa TA, Kato T, Mantani A, Ogawa Y, Tajika A, Takeshima N, Hayasaka Y, Shinohara K, Miki K, Inagaki M, Shimodera S, Akechi T, Yamada M, Watanabe N, Guyatt GH; SUN(;_;)D Investigators. Strategic use of new generation antidepressants for depression: SUN(;_;) D protocol update and statistical analysis plan. Trials. 2015 Oct 14;16:459. doi: 10.1186/s13063-015-0985-6.'}, {'pmid': '22682213', 'type': 'DERIVED', 'citation': 'Shimodera S, Kato T, Sato H, Miki K, Shinagawa Y, Kondo M, Fujita H, Morokuma I, Ikeda Y, Akechi T, Watanabe N, Yamada M, Inagaki M, Yonemoto N, Furukawa TA; SUN(;_;)D Investigators. The first 100 patients in the SUN(;_;)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase. Trials. 2012 Jun 8;13:80. doi: 10.1186/1745-6215-13-80.'}, {'pmid': '21569309', 'type': 'DERIVED', 'citation': 'Furukawa TA, Akechi T, Shimodera S, Yamada M, Miki K, Watanabe N, Inagaki M, Yonemoto N. Strategic use of new generation antidepressants for depression: SUN(;_;)D study protocol. Trials. 2011 May 11;12:116. doi: 10.1186/1745-6215-12-116.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition \\[DSM-IV\\]) in the preceding month\n* age 25-75\n* starting treatment with sertraline clinically indicated\n* tolerability to sertraline 25 mg/d ascertained\n* can understand and sign informed consent form\n* can be contacted by telephone for symptom severity and adverse events\n\nExclusion Criteria:\n\n* have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month\n* history of schizophrenia, schizoaffective disorder or bipolar disorder\n* current dementia, borderline personality disorder, eating disorder or substance dependence\n* physical disease interfering with sertraline or mirtazapine treatment\n* allergy to sertraline or mirtazapine\n* terminal physical illness\n* currently pregnant or breast-feeding\n* high risk of imminent suicide\n* requiring compulsory admission\n* expected to change doctors within 6 months\n* cohabiting relatives of research staff\n* cannot understand Japanese'}, 'identificationModule': {'nctId': 'NCT01109693', 'acronym': 'SUN(^_^)D', 'briefTitle': 'Strategic Use of New Generation Antidepressants for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University Hospital'}, 'officialTitle': 'Strategic Use of New Generation Antidepressants for Depression', 'orgStudyIdInfo': {'id': 'sun-d'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continue sertraline', 'description': 'Continue sertraline at the dosage at 3 weeks', 'interventionNames': ['Drug: Sertraline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Augment with mirtazapine', 'description': 'Add mirtazapine to sertraline', 'interventionNames': ['Drug: Sertraline', 'Drug: Mirtazapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Switch to mirtazapine', 'description': 'Stop sertraline and switch to mirtazapine', 'interventionNames': ['Drug: Mirtazapine']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'description': 'Sertraline 50 mg/d or 100 mg/d for 6 more weeks', 'armGroupLabels': ['Augment with mirtazapine', 'Continue sertraline']}, {'name': 'Mirtazapine', 'type': 'DRUG', 'description': 'Augment with or switch to mirtazapine 15-45 mg/d', 'armGroupLabels': ['Augment with mirtazapine', 'Switch to mirtazapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '783-8505', 'city': 'Nangoku', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School Hospital'}], 'overallOfficials': [{'name': 'Toshiaki A Furukawa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyoto University Graduate School of Medicine / School of Public Health'}, {'name': 'Tatsuo Akechi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nagoya City University Graduate School of Medical Sciences'}, {'name': 'Norio Watanabe, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Neurology and Psychiatry, Japan'}, {'name': 'Shinji Shimodera, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kochi University Medical School'}, {'name': 'Mitsuhiko Yamada, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Neurology and Psychiatry, Japan'}, {'name': 'Masatoshi Inagaki, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Okayama University Graudate School of Medicine'}, {'name': 'Naohiro Yonemoto, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Neurology and Psychiatry, Japan'}, {'name': 'Kazuhira Miki, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Miki Mental Clinic, Yokohama, Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Neurology and Psychiatry, Japan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Toshiaki A. Furukawa', 'investigatorAffiliation': 'Kyoto University'}}}}