Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-28 @ 3:30 AM
Study NCT ID:
NCT07002034
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000275', 'term': 'Adjustment Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score', 'timeFrame': 'Day 7', 'description': 'Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.'}], 'secondaryOutcomes': [{'measure': 'RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)', 'timeFrame': 'Day 7', 'description': 'The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.'}, {'measure': 'RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.', 'timeFrame': 'From dosing through study completion (post-dose follow-up is for 42 days)', 'description': 'A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Amyotrophic Lateral Sclerosis (ALS)', 'Multiple Sclerosis (MS)', 'Parkinson's Disease (PD)', 'Idiopathic Pulmonary Fibrosis (IPF)', 'Depression', 'Anxiety', 'Psychiatric Distress'], 'conditions': ['Adjustment Disorder']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF\n* Is sufficiently ambulatory and capable of self care as necessary to complete study procedures\n* Has normal cognitive function\n* Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study\n* If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant\n* Is willing and able to comply with the conditions and requirements of the study\n\nExclusion Criteria:\n\n* Has a significant risk of suicide\n* Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder\n* Has active or a history of central nervous system malignancy\n* Has other medically significant conditions rendering unsuitability for the study\n* Has used or will need to use prohibited medications or therapies\n* Has a known sensitivity or intolerance to study intervention or potential rescue medications'}, 'identificationModule': {'nctId': 'NCT07002034', 'briefTitle': 'RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reunion Neuroscience Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses', 'orgStudyIdInfo': {'id': 'RE104-202-ADCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.5 mg RE104', 'description': 'A single subcutaneous injection of 1.5 mg RE104 for Injection', 'interventionNames': ['Drug: RE104 for Injection']}, {'type': 'EXPERIMENTAL', 'label': '30 mg RE104', 'description': 'A single subcutaneous injection of 30 mg RE104 for Injection', 'interventionNames': ['Drug: RE104 for Injection']}], 'interventions': [{'name': 'RE104 for Injection', 'type': 'DRUG', 'description': 'Single, subcutaneous dose of RE104 for Injection', 'armGroupLabels': ['1.5 mg RE104', '30 mg RE104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 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'gabriel_najarian@dfci.harvard.edu'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48377', 'city': 'Novi', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Atena Gutierrrez', 'role': 'CONTACT', 'email': 'agutier1@hfhs.org'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hector Garcia', 'role': 'CONTACT', 'email': 'hecgarcia@salud.unm.edu'}], 'facility': 'University of New Mexico, School of Medicine', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Hawkins', 'role': 'CONTACT', 'email': 'jessica.hawkins@nyulangone.org'}], 'facility': 'NYU Langone Center for Psychedelic Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Grace Kozik', 'role': 'CONTACT', 'email': 'rachel_kozik@med.unc.edu'}], 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne-Marie Duchemin', 'role': 'CONTACT', 'email': 'anne-marie.duchemin@osumc.edu'}], 'facility': 'The Ohio State University, Department of Psychiatry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Blase', 'role': 'CONTACT', 'email': 'erin.blase@pennmedicine.upenn.edu', 'phone': '215-746-6419'}], 'facility': 'University of 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{'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Mark Pollack, Chief Medical Officer', 'role': 'CONTACT', 'email': 'info@reunionneuro.com', 'phone': '1-888-880-REUN'}], 'overallOfficials': [{'name': 'Mark Pollack, Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reunion Neuroscience Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing will be consistent with the results submission policy of ClinicalTrials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reunion Neuroscience Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}