Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:15 PM
Study NCT ID:
NCT07472920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empagliflozin Adjunctive Therapy in Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study; no masking will be used.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single-arm, proof-of-concept trial evaluating the effects of empagliflozin as an adjunctive treatment for bipolar depression.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depressive symptom severity (MADRS total score)', 'timeFrame': 'Baseline and 12 weeks after treatment initiation', 'description': 'The Montgomery-Åsberg Depression Rating Scale (MADRS) will be used to assess depressive symptom severity. The scale includes 10 clinician-rated items, with higher scores indicating more severe depression. The primary outcome is the change in total MADRS score from baseline to week 12 of treatment with empagliflozin.'}], 'secondaryOutcomes': [{'measure': 'Change in insulin resistance (HOMA-IR)', 'timeFrame': 'Baseline and 12 weeks after treatment initiation', 'description': 'Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and insulin levels. The outcome will be the change in HOMA-IR from baseline to week 12.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': 'Throughout the 12-week study period', 'description': 'Adverse events will be recorded throughout the 12-week study period. Safety will be assessed through adverse event monitoring, clinical evaluation, and laboratory tests (including renal function and electrolytes).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar Disorder', 'Bipolar Depression', 'Insulin Resistance', 'Empagliflozin', 'SGLT2 Inhibitors', 'Metabolic Psychiatry'], 'conditions': ['Bipolar Disorder', 'Bipolar Depression', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options.\n\nRecent research shows that insulin resistance (IR), a condition in which the body does not respond well to insulin, is common in people with bipolar disorder. It is linked to more severe mood symptoms, poorer treatment response, and higher risk of heart disease. IR may raise inflammation and affect how the brain uses energy, which can influence mood regulation.\n\nEmpagliflozin is a medicine approved for type 2 diabetes. In addition to its metabolic and heart benefits, studies suggest that it may also protect the brain and reduce inflammation, possibly helping to improve mood.\n\nThis open-label, proof-of-concept clinical trial will test how well empagliflozin works and how safe it is as an add-on treatment for people with bipolar depression and insulin resistance. A total of 20 adults with bipolar disorder type I or II, currently in a depressive episode, will take part in the study over a 12-week period.\n\nThe main goal is to see whether empagliflozin can lower depressive symptoms, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Other measures include changes in insulin resistance and incidence of adverse events.\n\nThe study aims to explore whether improving insulin resistance can help both mood and metabolic health in people with bipolar disorder, guiding future clinical research.', 'detailedDescription': 'This study is an open-label, single-arm, proof-of-concept clinical trial evaluating empagliflozin as an adjunctive treatment for bipolar depression in individuals with insulin resistance. Adults with bipolar disorder type I or II who are currently experiencing a depressive episode and receiving stable pharmacological treatment will receive empagliflozin for 12 weeks.\n\nDepressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Insulin resistance will be evaluated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and safety will be monitored through assessment of treatment-emergent adverse events throughout the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 to 65 years.\n2. Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.\n3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.\n4. Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.\n5. Ability to provide informed consent.\n6. Insulin resistance, defined as HOMA-IR ≥ 1.8.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.\n2. Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.\n3. Known pancreatic disease (pancreatitis or pancreatic surgery).\n4. Chronic kidney disease (eGFR \\< 30 mL/min/1.73m²).\n5. Recurrent genital fungal infections.\n6. Pregnant or breastfeeding.\n7. Alcohol abuse or dependence within the past 12 months.\n8. YMRS score ≥ 12 (presence of manic or hypomanic symptoms).'}, 'identificationModule': {'nctId': 'NCT07472920', 'acronym': 'EMPA-BD', 'briefTitle': 'Empagliflozin Adjunctive Therapy in Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)', 'orgStudyIdInfo': {'id': '86886125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin Adjunctive Therapy in Bipolar Depression', 'description': 'Participants will receive empagliflozin orally once daily as an adjunct to their usual psychiatric treatment. The dose will start at 10 mg/day for the first 2 weeks and increase to 25 mg/day for the following 10 weeks, totaling a 12-week intervention period. The study will evaluate changes in depressive symptoms, insulin resistance, and metabolic parameters in adults with bipolar depression and insulin resistance. All participants will continue their standard psychiatric medications under medical supervision throughout the study.', 'interventionNames': ['Drug: Empagliflozin (EMPA)']}], 'interventions': [{'name': 'Empagliflozin (EMPA)', 'type': 'DRUG', 'otherNames': ['Jardiance'], 'description': 'Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally once daily. Participants will start with 10 mg/day for the first 2 weeks, followed by 25 mg/day for the next 10 weeks, completing a 12-week intervention period. The drug will be used as an adjunctive treatment to standard psychiatric therapy in adults with bipolar depression and insulin resistance. Safety and tolerability will be monitored throughout the study.', 'armGroupLabels': ['Empagliflozin Adjunctive Therapy in Bipolar Depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-903', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Eliana Landivar', 'role': 'CONTACT', 'email': 'eliana.landivar@hc.fm.usp.br', 'phone': '+55 11 2661 7890'}, {'name': 'Eliana Landivar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Eliana Landivar, MD', 'role': 'CONTACT', 'email': 'eliana.landivar@hc.fm.usp.br', 'phone': '+55 11 2661 7890'}], 'overallOfficials': [{'name': 'Beny Lafer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) will not be shared because this is a small, proof-of-concept, single-site study. The dataset includes sensitive clinical information that could potentially identify participants. Only aggregated and anonymized results will be shared in future scientific publications or presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical school of the University of São Paulo (FMUSP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Beny Lafer', 'investigatorAffiliation': 'University of Sao Paulo'}}}}