Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT06809595
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-01-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
Sponsor:
Organization:
Raw JSON
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Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1', 'timeFrame': 'Week 8, Week 4, Week 2, and Week 1', 'description': 'The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period', 'timeFrame': 'Baseline to Week 12', 'description': 'The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period', 'timeFrame': 'Baseline to Week 12', 'description': 'The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period', 'timeFrame': 'Day 2 to Week 12', 'description': "The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening."}, {'measure': 'Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score', 'timeFrame': 'Baseline to Week 12', 'description': "The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness."}, {'measure': 'Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score', 'timeFrame': 'Baseline to Week 12', 'description': 'The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.'}, {'measure': 'Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Montgomery-Åsberg Depression Rating Scale (MADRS) total score', 'timeFrame': 'Baseline to Week 12', 'description': 'The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.'}, {'measure': 'Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Work Productivity and Activity Impairment Questionnaire (WPAI)', 'timeFrame': 'Baseline to Week 12', 'description': 'The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.'}, {'measure': 'Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)', 'timeFrame': 'Baseline to Week 12', 'description': 'The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).'}, {'measure': 'Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period', 'timeFrame': 'Baseline to Week 12', 'description': 'The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.'}, {'measure': 'Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period', 'timeFrame': 'Baseline to Week 12', 'description': 'The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.'}, {'measure': 'Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period', 'timeFrame': 'Day 1 to Week 52', 'description': 'Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period'}, {'measure': 'Time to first treatment or lack of efficacy in the open-label period (Part B)', 'timeFrame': 'Day 1 to Week 52', 'description': 'Measured as time from first dosing in the Double-blind period to participant meeting HAM-A criteria for re-dose or meeting criteria for lack of efficacy'}, {'measure': 'Need for MM120 treatment as assessed by the average number of MM120 treatments during the study', 'timeFrame': 'Day 1 to Week 52', 'description': 'Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension.'}, {'measure': 'HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period', 'timeFrame': '40 week open label period', 'description': 'The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period', 'timeFrame': '40 week open label period', 'description': 'The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.'}, {'measure': 'Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score', 'timeFrame': 'Baseline to Week 52', 'description': "The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness."}, {'measure': 'Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score', 'timeFrame': 'Baseline to Week 52', 'description': 'The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.'}, {'measure': 'Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score', 'timeFrame': 'Baseline to Week 52', 'description': 'The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.'}, {'measure': 'Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI', 'timeFrame': 'Baseline to Week 52', 'description': 'The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.'}, {'measure': 'Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L', 'timeFrame': 'Baseline to Week 52', 'description': 'The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).'}, {'measure': 'CSFQ-14 total score at each timepoint assessed during the open-label period', 'timeFrame': '40 week open label period', 'description': 'The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.'}, {'measure': 'Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period', 'timeFrame': '40 week open label period', 'description': 'The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Panorama', 'detailedDescription': 'The study will enroll up to 375 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.\n\nThe study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of GAD per DSM-5\n2. Male or female aged 18 to 74\n3. HAM-A Total Score ≥20\n\nExclusion Criteria:\n\n1. Certain psychiatric disorders (other than generalized anxiety disorder)\n2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder\n3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)\n4. Any clinically significant unstable illness'}, 'identificationModule': {'nctId': 'NCT06809595', 'briefTitle': 'A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mind Medicine, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40 Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Panorama', 'orgStudyIdInfo': {'id': 'MM120-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1 - Placebo', 'description': 'A substance that is designed to have no therapeutic value', 'interventionNames': ['Other: Placebo']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arm 2 - 50µg MM120 (LSD D-Tartrate)', 'description': 'A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)', 'interventionNames': ['Drug: MM120 (LSD D-Tartrate)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 - 100µg MM120 (LSD D-Tartrate)', 'description': 'A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)', 'interventionNames': ['Drug: MM120 (LSD D-Tartrate)']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'A substance that is designed to have no therapeutic value', 'armGroupLabels': ['Arm 1 - Placebo']}, {'name': 'MM120 (LSD D-Tartrate)', 'type': 'DRUG', 'description': 'A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)', 'armGroupLabels': ['Arm 2 - 50µg MM120 (LSD D-Tartrate)', 'Arm 3 - 100µg MM120 (LSD D-Tartrate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacy Tierney', 'role': 'CONTACT', 'email': 'stierney@preferredresearchpartners.com', 'phone': '501-553-9987', 'phoneExt': '111'}], 'facility': 'Preferred Research Partners, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90004', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keith Heinzerling', 'role': 'CONTACT', 'email': 'trialadmin@psychedelicsci.com', 'phone': '310-996-8966'}], 'facility': 'Psychedelic Science Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Walter Dunn, MD, PhD', 'role': 'CONTACT', 'email': 'Walter.Dunn@va.gov', 'phone': '310-478-3711', 'phoneExt': '49234'}], 'facility': 'West Los Angeles VA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90504', 'city': 'Torrance', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Cenexel-CNS', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Folkens', 'role': 'CONTACT', 'email': 'info@bradentonresearch.com', 'phone': '941-708-0005'}], 'facility': 'Bradenton Research Center, Inc.', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chanel Adams', 'role': 'CONTACT', 'email': 'cadams@cnshealthcare.com', 'phone': '407-425-5100'}], 'facility': 'Clinical Neuroscience Solutions, Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': 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'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet Jimenez', 'role': 'CONTACT', 'email': 'janet.jimenez@numinus.com', 'phone': '385-390-3166'}], 'facility': 'Cedar Clinical Research', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Golescu', 'role': 'CONTACT', 'email': 'maria.golescu@ccrtrial.com', 'phone': '425-443-9551'}], 'facility': 'Core Clinical Research', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'city': 'Pilsen', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'A-shine s.r.o.', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Institut Neuropsychiatricke Pece (INEP)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 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Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und Psychotherapie', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Centrum Badan Klinicznych PI-House sp. z o.o.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Department of Psychiatry, UCK', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': '4 Medical Clinical Solutions', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clerkenwell Health - Baker Street', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clerkenwell Health', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'South London and Maudsley NHS Foundation Trust of The Maudsley Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': '4 Medical Clinical Solutions', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Mind Medicine, Inc. Clinical Trials Info Requests', 'role': 'CONTACT', 'email': 'ClinicalTrials@Mindmed.co', 'phone': '1-332-282-0479'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mind Medicine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}