Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:42 PM
Study NCT ID:
NCT07412132
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'week 12', 'description': 'The efficacy of lacosamide assessed by the difference in Hamilton Depression Scale score from the initial visit to the end of week 12 of the intervention between the lacosamide and placebo groups. Minimum: 0 point Maximum: 50 points. The increase in the pontuation of the scale is related to worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': 'week 12', 'description': 'Difference in response rates (50% or more reduction) assessed by the Hamilton Depression Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups;'}, {'measure': 'Secondary outcome', 'timeFrame': 'week 12', 'description': 'Difference in response rates (50% or more reduction) assessed by the Montgomery-Asberg Depression Rate Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups;'}, {'measure': 'Secondary outcome', 'timeFrame': 'week 12', 'description': 'Difference in remission rates (\\< 7 points) assessed by the Hamilton Depression Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups;'}, {'measure': 'Secondary outcome', 'timeFrame': 'week 12', 'description': 'Difference in remission rates (\\<11 points) assessed by the Montgomery-Asberg Depression Rate Scale from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups;'}, {'measure': 'Secondary outcome', 'timeFrame': 'week 12', 'description': 'Difference in side effects from the initial visit to the end of week 12 of intervention, between the lacosamide and placebo groups;'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lacosamide', 'randomized clinical trial', 'bipolar disorder', 'bipolar depression'], 'conditions': ['Bipolar Affective Disorder']}, 'descriptionModule': {'briefSummary': 'Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview;\n2. acute major depressive episode of moderate or severe intensity;\n3. no response to at least two adequate pharmacological interventions to treat the current episode.\n\nExclusion Criteria:\n\n1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;\n2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);\n3. current depressive episode with psychotic features (by clinical assessment);\n4. suspected or confirmed pregnancy;\n5. severe or unstable clinical illnesses;\n6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;\n7. previous history of non-response to an adequate course of ketamine treatment.'}, 'identificationModule': {'nctId': 'NCT07412132', 'briefTitle': 'Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.', 'orgStudyIdInfo': {'id': 'Lacosamide on bipolar disorder'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Group', 'description': 'Lacosamide 50mg twice a day', 'interventionNames': ['Drug: Lacosamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'description': 'Lacosamide 50mg will be give twice a day por 2 weeks, then Lacosamide 100mg twice a day until the end of the study.', 'armGroupLabels': ['Active Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets are similar in its features to the active drug, but without any pharmacological agent inside.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'email': 'grudaipq@hc.fm.usp.br', 'phone': '+55 (11) 2661-6648'}], 'facility': 'Instituto de Psiquiatia (IPQ)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ricardo Alberto Moreno, Professor', 'role': 'CONTACT', 'email': 'grudaipq@hc.fm.usp.br', 'phone': '+55 11 2661-6648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Libbs Farmacêutica LTDA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorate', 'investigatorFullName': 'Diego Freitas Tavares', 'investigatorAffiliation': 'University of Sao Paulo'}}}}