Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-04 @ 8:01 PM
Study NCT ID:
NCT06687694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Mechanisms of Antipsychotic Treatment Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012569', 'term': 'Schizotypal Personality Disorder'}, {'id': 'D012753', 'term': 'Shared Paranoid Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000087122', 'term': 'Mania'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and cerebrospinal fluid.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral Immune Phenotype', 'timeFrame': '4 +/-2 weeks', 'description': 'Change in the flow cytometric peripheral immune phenotype following treatment with antipsychotic medication.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Antipsychotic', 'Neuroimmunology', 'Inflammation', 'Autoantibody', 'Schizophrenia', 'Schizotypal disorder', 'Persistent delusional disorders', 'Acute and transient psychotic disorders', 'Induced delusional disorder', 'Schizoaffective disorders', 'Other nonorganic psychotic disorders', 'Unspecified nonorganic psychosis', 'Manic episode', 'Bipolar affective disorder', 'Depressive episode', 'Recurrent depressive disorder', 'Persistent mood [affective] disorders', 'Other mood [affective] disorders', 'Unspecified mood [affective] disorder'], 'conditions': ['Psychosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment. The investigators will collect blood and cerebrospinal fluid samples from participants with psychosis symptoms who are about to start or change to a new regular antipsychotic treatment as well as a control group for comparison.\n\nParticipants will be assessed at two main timepoints, at visit 1 (Week 0) and at visit 2 (4 +/-2 weeks). For participants with psychosis symptoms visit 1 will take place at the start or change of antipsychotic medication. The studies goal is to identify biomarkers that can aid in diagnosis, prognosis, treatment selection, and tracking treatment response.\n\nThe investigators aim to recruit participants from the following groups:\n\n1. Individuals with psychosis symptoms presenting to acute or outpatient services who are due to be started on or change to a new regular antipsychotic medication.\n2. Age- and sex-matched control participants without neuropsychiatric disease.\n\nFindings could potentially impact the treatment of psychotic illnesses by offering mechanistic insights into targeted immune-based interventions for these disorders through high-resolution immunophenotyping techniques alongside targeted immunological assays. Ultimately, the research aims to contribute valuable resources for future studies exploring the connection between immune processes and neuropsychiatric conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with psychosis symptoms will be recruited from clinical services at participating sites. Control participants may be recruited via online and offline channels. This may include posting on social media platforms, sharing information with local research networks or databases and displaying adverts on notice boards in public places in collaborating universities and NHS facilities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Age 18-65\n* Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment.\n* Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team.\n* Due to start or change to a new regular antipsychotic medication. (Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.)\n\nControl Participants\n\n* Age 18-65\n* No active autoimmune disorder.\n* No history of psychosis symptoms.\n\nExclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nControl participants:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nOptional lumbar puncture only:\n\n* Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery.\n* Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.\n* Known or suspected clotting disorder.\n* Clinically significant abnormality in full blood count.\n* Known or suspected raised intracranial pressure, assessed by study clinician.\n* Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.\n* History of chronic or recurrent headaches, in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06687694', 'acronym': 'IMAT', 'briefTitle': 'Immune Mechanisms of Antipsychotic Treatment Response', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Immune Mechanisms of Antipsychotic Treatment Response', 'orgStudyIdInfo': {'id': '331728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with psychosis symptoms'}, {'label': 'Control Participants'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 8AB', 'city': 'London', 'state': 'United Kingdom', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas Pollak, PhD', 'role': 'CONTACT', 'email': 'thomas.pollak@kcl.ac.uk', 'phone': '+442078485288'}], 'facility': 'South London and Maudsley NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Thomas Pollak (Chief Investigator), PhD', 'role': 'CONTACT', 'email': 'thomas.pollak@kcl.ac.uk', 'phone': '+442078485288'}, {'name': 'Amy Aldridge (Project Manager)', 'role': 'CONTACT', 'email': 'amy.l.aldridge@kcl.ac.uk', 'phone': '+442078485288'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'South London and Maudsley NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'McPin Foundation', 'class': 'OTHER'}, {'name': 'Francis Crick Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}