Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-27 @ 2:05 AM
Study NCT ID:
NCT04597450
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task', 'timeFrame': 'Day 15', 'description': 'fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Facial Affect Recognition Task'}, {'measure': 'Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task', 'timeFrame': 'Day 15', 'description': 'fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Threat Processing Task'}, {'measure': 'Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task', 'timeFrame': 'Day 15', 'description': 'fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Card Guessing Task'}, {'measure': 'Skin Conductance Response (SCR) During fMRI Tasks', 'timeFrame': 'Day 15', 'description': 'SCR in micro-Siemens'}, {'measure': 'Skin Conductance Response (SCR) During the Threat Processing Task', 'timeFrame': 'Day 14', 'description': 'SCR in micro-Siemens'}, {'measure': 'Behavioural Measures During fMRI Tasks', 'timeFrame': 'Day 15', 'description': 'Behavioural Response: behavioural measures rated on a 3-point scale'}, {'measure': 'Behavioural Measures During the Threat Processing Task', 'timeFrame': 'Day 14', 'description': 'Behavioural Response: behavioural measures rated on a 3-point scale'}, {'measure': 'Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)', 'timeFrame': 'Day 12-13', 'description': 'TST in minutes'}, {'measure': 'Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)', 'timeFrame': 'Day 12-13', 'description': 'SE in percent'}, {'measure': 'Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)', 'timeFrame': 'Day 12-13', 'description': 'WASO in minutes'}, {'measure': 'Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)', 'timeFrame': 'Day 12-13', 'description': 'SOL in minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.', 'detailedDescription': 'The crossover study consists of two treatment periods of 15 days duration. On Day -1 or Day 1 of Treatment Period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466) with 15 participants are planned per sequence. Each treatment period will be separated by a washout period of ≥7 and ≤14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has PTSD, diagnosed according to Diagnostic and Statistical Manual Diploma in Social Medicine-5 (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).\n* The participant has a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥28 at screening and baseline.\n* The participant has alterations in arousal and reactivity, confirmed on CAPS-5.\n* The participant has ongoing sleep disturbances, confirmed on CAPS-5.\n* The participant is willing to discontinue all prohibited medications during the study and to complete a washout of psychotropic medication during the washout period.\n* The participant does not have any magnetic resonance imaging (MRI) contraindications.\n\nExclusion Criteria:\n\n* The index traumatic event that led to development of PTSD took place \\>15 years or \\<6 months before screening.\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04597450', 'briefTitle': 'Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Exploratory Study Investigating the Effects of Lu AG06466 on BOLD fMRI Signals and Sleep Parameters in Patients With PTSD', 'orgStudyIdInfo': {'id': '19364A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AG06466', 'interventionNames': ['Drug: Lu AG06466']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lu AG06466', 'type': 'DRUG', 'description': 'Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period', 'armGroupLabels': ['Lu AG06466']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative NeuroScience Network LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@Lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}