Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 1:12 AM
Study NCT ID:
NCT07011693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'C084711', 'term': 'agomelatine'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], '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': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "response rate of Children's Depression Rating Scale (CDRS-R) scores", 'timeFrame': 'Baseline of treatment period, 4 weeks, 8 weeks', 'description': 'The primary outcomes are the treatment response rate (reduction rate of CDRS-R≥50%). The CDRS-R is a scale consisting of 17 items that are evaluated by clinicians to assess the intensity of depressive symptoms in adolescents, with items scored on scales of 1 to 5 or 1 to 7, resulting in a possible total score range of 17 to 113，higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Baker Depression Scale（BDI-II) scores from baseline', 'timeFrame': 'Baseline of treatment period, 4 weeks, 8 weeks', 'description': 'Change in BDI-II scores from baseline，The BDI is a self-report rating scale containing 21 items. Based on the BDI scores, depression can be classified into six levels: normal (1-10), mild mood disorder (11-16), borderline clinical depression (17-20), moderate depression (21-30), severe depression (31-40), and extreme depression (over 40).Higher scores mean a worse outcome.'}, {'measure': 'Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline', 'timeFrame': 'Baseline of treatment period, 4 weeks，8 weeks', 'description': 'The SCARED is employed to evaluate child anxiety symptoms. Each question is rated from 0 to 2, with 0 denoting "not true or hardly ever true," 1 denoting "somewhat true or sometimes true", and 2 denoting "extremely true or often true". The maximum total score is 63. Higher scores mean a better or worse outcome.'}, {'measure': 'Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline', 'timeFrame': 'Baseline of treatment period, 4 weeks, 8 weeks,', 'description': 'Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged'}, {'measure': 'Adverse Event (AE) or Serious Adverse Event (SAE)', 'timeFrame': 'Baseline of treatment period, 1 month, 2 months,', 'description': 'Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale), Adverse Event (AE) or Serious Adverse Event (SAE)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent', 'SSRI', 'depression'], 'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.', 'detailedDescription': 'This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 12-17;\n2. As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;\n3. CDRS-R≥45;\n4. CGI-S≥4;\n5. Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.\n\nExclusion Criteria:\n\n1. Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;\n2. MDD with psychotic symptoms;\n3. YMRS\\>13;\n4. Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;\n5. Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);\n6. History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;\n7. Current depressive episode with clear suicidal plans or behaviors;\n8. Received modified electroconvulsive therapy within 3 months;\n9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;\n10. Substance abuse or dependence;\n11. Female patients with pregnancy.'}, 'identificationModule': {'nctId': 'NCT07011693', 'acronym': 'SMART-I', 'briefTitle': 'Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1stChongqingCQMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1-sertraline', 'description': 'dosage form: po dosage:25-200mg frequency:qd duration: patients will be given sertraline as a switching treatment to SSRI.', 'interventionNames': ['Drug: Sertraline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2-agomelatine', 'description': 'dosage form: po dosage:25-50mg frequency:qd duration: patients will be given agomelatine as a switching treatment to SSRI.', 'interventionNames': ['Drug: Agomelatine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3-aripiprazole with original SSRI', 'description': 'dosage form: po dosage: 1.25-15mg frequency:qn duration: patientswill be given aripiprazole as an add-on treatment to original SSRI.', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Group1-sertraline']}, {'name': 'Agomelatine', 'type': 'DRUG', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Group 2-agomelatine']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Group 3-aripiprazole with original SSRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Xinyu Zhou', 'role': 'CONTACT', 'email': 'zhouxinyu@cqmu.edu.cn', 'phone': '2912-89012912'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xinyu Zhou', 'role': 'CONTACT', 'email': 'zhouxinyu@cqmu.edu.cn', 'phone': '2912-89012912'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinyu Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professer', 'investigatorFullName': 'Xinyu Zhou', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}