Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 10:11 PM
Study NCT ID:
NCT06605105
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 468}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196, Day 244, Day 252, Day 280, Day 301; additional assessments at Day -15, Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 42 if non-response or relapse criteria met', 'description': 'The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity. The scale consists of ten items rated on a scale from 0 to 6, resulting in a total score ranging from 0 (normal / symptom absent) to 60 (severe depression).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'MDD', 'Psilocybin', 'Psychedelic', 'CYB003', 'Depression', 'CYB003-002', 'Long-Term Extension', 'CYB003-003'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication\n* Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE\n* Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form\n* Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP\n* Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP\n* Female participants must have a negative pregnancy test at Baseline (the end of trial \\[EOT\\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day\n\nExclusion Criteria:\n\n* newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial\n* Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation/attempt or self-harm in CYB003-002 APPROACH OR has had a \\>1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH\n* Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial\n* Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND\n* Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial\n* Positive urine test for drugs of abuse, or alcohol breath test prior to dosing.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions"}, 'identificationModule': {'nctId': 'NCT06605105', 'acronym': 'EXTEND', 'briefTitle': 'Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cybin IRL Limited'}, 'officialTitle': 'A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)', 'orgStudyIdInfo': {'id': 'CYB003-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYB003', 'description': 'Initial non-responders in CYB003-002 APPROACH and CYB003-003 EMBRACE, or initial responders who later relapse will be eligible to receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. If a participant relapses again, the participant may receive an additional single 16mg of CYB003 (maximum of 3 16mg doses in CYB003-004 EXTEND). Participants will continue on their current antidepressants and receive psychological support throughout the study.', 'interventionNames': ['Drug: CYB003']}], 'interventions': [{'name': 'CYB003', 'type': 'DRUG', 'description': 'CYB003 is a deuterated psilocin analog', 'armGroupLabels': ['CYB003']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Phillip Perl', 'role': 'CONTACT', 'email': 'phillip@openmindcollective.org', 'phone': '612-802-3615'}, {'name': 'Sidney Edsall, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Open Mind Collective / UCSF Medical Center - Mount Zion', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 's.diaz@cenexel.com', 'phone': '954-990-7649'}, {'name': 'Edwin Gomez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Centers of America', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kadian Watson', 'role': 'CONTACT', 'email': 'kwatson@segaltrials.com', 'phone': '786-570-1971'}, {'name': 'Rishi Kakar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Segal Trials Center for Psychedelic Research', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '30030', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'w.smith-byrd@cenexel.com', 'phone': '404-537-1281'}, {'name': 'Kimball Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cenexel iResearcvh Atlanta, LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denniel Brown', 'role': 'CONTACT', 'email': 'd.brown@cenexel.com', 'phone': '404-881-5800'}, {'name': 'Elyssa Barron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atlanta Center For Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Rhode', 'role': 'CONTACT', 'email': 'jrohde@uptownresearch.com', 'phone': '773-989-8313', 'phoneExt': '114'}, {'name': 'John Sonnenberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uptown Research Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Nagelvoort', 'role': 'CONTACT', 'email': 'Nicole.nagelvoort@sunstonetherapies.com', 'phone': '301-323-8249'}, {'name': 'Minish Agrawal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunstone Medical, PC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'mmoy@adamsclinical.com', 'phone': '617-744-8542'}, {'name': 'Daniel Rutrick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adams Clinical', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'seast@adamsclinical.com', 'phone': '972-283-6286'}, {'name': 'Rajinder Shiwach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'InSite Clinical Research, LLC', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mandi Rigby', 'role': 'CONTACT', 'email': 'mandi.rigby@numinusnetwork.com', 'phone': '801-369-4219'}, {'name': 'Paul Thielking, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedar Clinical Research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}], 'centralContacts': [{'name': 'Clinical Development', 'role': 'CONTACT', 'email': 'clinicaltrialsinfo@cybin.com', 'phone': '1-866-292-4601', 'phoneExt': '799'}], 'overallOfficials': [{'name': 'Clinical Development', 'role': 'STUDY_CHAIR', 'affiliation': 'Cybin IRL Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cybin IRL Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}