Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 4:44 AM
Study NCT ID:
NCT05117632
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALTO-100 in MDD and/or PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2023-11-29', 'completionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'dispFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': 'Measured 5 times over 8 weeks', 'description': 'The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.'}, {'measure': 'To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)', 'timeFrame': 'Measured 5 times over 8 weeks', 'description': 'The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.'}, {'measure': 'To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)', 'timeFrame': 'Measured 3 times over 8 weeks', 'description': 'The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. The change from baseline to the end of the study is the primary outcome.'}, {'measure': 'Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100', 'timeFrame': 'From the signing of the ICF until the follow-up visit (up to 12 weeks)', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}, {'measure': 'Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100', 'timeFrame': 'From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)', 'description': 'Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100', 'timeFrame': 'From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)', 'description': 'Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)\n* At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks\n* Willing to comply with all study assessments and procedures\n* Must not be pregnant or breastfeeding at time of enrollment or throughout study\n\nExclusion Criteria:\n\n* Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease\n* Active suicidal ideation\n* Diagnosed bipolar disorder, psychotic disorder, or dementia\n* Current moderate or severe substance use disorder\n* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients\n* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device'}, 'identificationModule': {'nctId': 'NCT05117632', 'briefTitle': 'ALTO-100 in MDD and/or PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alto Neuroscience'}, 'officialTitle': 'An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'ALTO-100-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALTO-100', 'description': 'ALTO-100 PO tablet, daily dosing 8 weeks', 'interventionNames': ['Drug: ALTO-100 PO tablet']}], 'interventions': [{'name': 'ALTO-100 PO tablet', 'type': 'DRUG', 'description': 'one tablet twice daily', 'armGroupLabels': ['ALTO-100']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 136', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Site 139', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Site 141', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '93703', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Site 118', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94553', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Site 116', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '95655', 'city': 'Mather', 'state': 'California', 'country': 'United States', 'facility': 'Site 116', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 150', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 112', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '60123', 'city': 'Elgin', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site 155', 'geoPoint': {'lat': 42.03725, 'lon': -88.28119}}, {'zip': '46060', 'city': 'Noblesville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site 137', 'geoPoint': {'lat': 40.04559, 'lon': -86.0086}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 151', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site 109', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Site 108', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Site 142', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Site 144', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 146', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 147', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76244', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 148', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 120', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 113', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 121', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 105', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'NTC Seattle (105a)', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alto Neuroscience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}