Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT01907568
Status:
UNKNOWN
Last Update Posted:
2016-10-26
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Hallucinations (Part I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006212', 'term': 'Hallucinations'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of clusters of patients with shared symptom profiles as determined by latent class analysis, and the difference in scores on cognitive assessment between these identified clusters.', 'timeFrame': 'Three years'}], 'secondaryOutcomes': [{'measure': 'The internal consistency, test-retest reliability, inter-rater reliability, criterion validity and construct validity of a newly developed questionnaire.', 'timeFrame': 'Two years'}, {'measure': 'The difference in scores on cognitive assessment between participant groups with and without psychotic symptoms.', 'timeFrame': 'Three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hallucinations', 'No Hallucinations']}, 'descriptionModule': {'briefSummary': 'Psychotic symptoms (hallucinations and delusions) are present in several psychiatric and neurological disorders as well as in the general population. Effective treatment strategies for these symptoms in all patients are lacking and treatment-response can presently not be predicted. To date, the exact pathophysiological mechanism of these symptoms remains unknown. By investigating (subtypes) of hallucinations and delusions in all populations, a common pathway may be found, leading to more effective treatment options. Alternatively, different subtypes may be associated with different pathophysiological mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We aim to include subjects of each of the following diagnostic groups, both with and without psychotic symptoms:\n\n1. patients with schizophrenia spectrum disorders\n2. patients with borderline personality disorder (BPD)\n3. patients with hearing impairment\n4. patients with visual loss\n5. patients with Parkinson's disease (PD)\n6. patients with Alzheimer's disease (AD)\n7. patients with Lewy Body dementia (DLB)\n8. patients with post-traumatic stress disorder (PTSD)\n9. patients with delirium\n10. healthy individuals\n11. patients with mood disorder", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* mentally competent\n* in case of delirium: family member able to give informed consent\n* Individuals with hallucinations will have to experience at least one episode of hallucinations over the last month.\n* Individuals without hallucinations: no current hallucinations and a history of maximum 1 episode of hallucinations with a maximum duration of 1 week, at least two years ago.\n\nExclusion Criteria:\n\n* Age \\<18)\n* Participants that cannot read, speak or understand Dutch\n* For all included diagnostic groups except delirium: Mentally incompetent individuals who are not capable to provide informed consent, as determined by their treating physician.'}, 'identificationModule': {'nctId': 'NCT01907568', 'acronym': 'UH-1', 'briefTitle': 'Understanding Hallucinations (Part I)', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Understanding Hallucinations (Part I) - Phenomenology and Cognition', 'orgStudyIdInfo': {'id': 'UH-1'}, 'secondaryIdInfos': [{'id': 'NL42959.041.13', 'type': 'OTHER', 'domain': 'Toetsingonline'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with schizophrenia', 'description': 'With and without hallucinations'}, {'label': 'Patients with borderline personality disorder', 'description': 'With and without hallucinations'}, {'label': 'Patients with hearing impairment', 'description': 'With and without hallucinations'}, {'label': 'Patients with visual loss', 'description': 'With and without hallucinations'}, {'label': "Patients with Parkinson's Disease", 'description': 'With and without hallucinations'}, {'label': "Patients with Alzheimer's Disease", 'description': 'With and without hallucinations'}, {'label': 'Patients with dementia with Lewy Bodies', 'description': 'With and without hallucinations'}, {'label': 'Patients with Posttraumatic Stress Disorder', 'description': 'With and without hallucinations'}, {'label': 'Patients with delirium', 'description': 'With and without hallucinations'}, {'label': 'Healthy participants', 'description': 'With and without hallucinations'}, {'label': 'Patients with mood disorder', 'description': 'With and without hallucinations'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Mascha Linszen, MD', 'role': 'CONTACT'}, {'name': 'Odile van den Heuvel, MD, PhD', 'role': 'CONTACT'}, {'name': 'Philip Scheltens, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Odile van den Heuvel, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Evelien Lemstra, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth Foncke, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'VU Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anne-Marthe Meppelink, MD', 'role': 'CONTACT'}, {'name': 'Teus van Laar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne-Marthe Meppelink, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marouska van Ommen, BSc.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UMC Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Karin Slotema, MD, PhD', 'role': 'CONTACT'}, {'name': 'Karin Slotema, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joop de Jong, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Parnassia Bavo Groep', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Mascha Linszen, MD', 'role': 'CONTACT', 'email': 'm.m.j.linszen@umcutrecht.nl', 'phone': '+31887557468'}, {'name': 'Sophie Heringa, PhD', 'role': 'CONTACT', 'email': 's.m.heringa@umcutrecht.nl', 'phone': '+31887557468'}, {'name': 'Iris Sommer, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Remko van Lutterveld, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sanne Koops, Msc.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arjen Slooter, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sophie Heringa, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maya Schutte, Msc.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mascha Linszen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Mascha M.J. Linszen, MD', 'role': 'CONTACT', 'email': 'm.m.j.linszen@umcutrecht.nl', 'phone': '+31887557468'}, {'name': 'Sophie M. Heringa, PhD', 'role': 'CONTACT', 'email': 's.m.heringa@umcutrecht.nl'}], 'overallOfficials': [{'name': 'Iris Sommer, Prof, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Teus van Laar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Groningen'}, {'name': 'Philip Scheltens, Prof, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Karin Slotema, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parnassia Groep'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Free University Medical Center', 'class': 'OTHER'}, {'name': 'Parnassia Groep', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Iris Sommer', 'investigatorAffiliation': 'UMC Utrecht'}}}}