Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT00204061
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D062706', 'term': 'Prodromal Symptoms'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077582', 'term': 'Amisulpride'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of risk related symptoms', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Decrease of symptom scores; complete remission of risk related symptoms'}], 'secondaryOutcomes': [{'measure': 'Global functioning', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Increase of Global Assessment of Functioning (GAF) scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'psychosis', 'ultra high risk', 'prodromal state', 'early intervention', 'amisulpride'], 'conditions': ['Schizophrenia', 'Psychoses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kompetenznetz-schizophrenie.de', 'label': 'Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis'}, {'url': 'http://www.fetz.de', 'label': 'Homepage of co-ordinating center'}]}, 'descriptionModule': {'briefSummary': 'The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.', 'detailedDescription': 'The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. General criteria\n\n * Age between 14 and 36 years\n * male or female, in- or outpatients\n * written informed consent, for patients below 18 years also signed by parents\n2. Special criteria (present within the last three months prior to the study)\n\n * Attenuated Positive Symptoms (APS)\n * Presence of at least one of the following symptoms: ideas of reference, odd beliefs or magical thinking, unusual perceptual experiences, odd thinking and speech, suspiciousness or paranoid ideation\n * Symptoms have to appear several times per week for a period of at least one week\n\nAND / OR\n\n* Brief Limited Intermittent Psychotic Symptoms (BLIPS)\n* Duration of episode less than one week, interval between episodes at least one week\n* Symptoms resolve spontaneously\n* Presence of at least one of the following symptoms: Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of schizophrenia, schizophreniform,schizoaffective, delusional or bipolar disorder, at any time of life.\n* DSM-IV diagnosis of brief psychotic episode with a duration of more than one week, at any time time of life, or BLIPS within one week before inclusion.\n* DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances.\n* Abuse of alcohol or drugs within the last three months prior to the study; exception: cannabis user have to be drug-free during four weeks prior to the study. In case of drug abuse, it has to be determined, whether present prodromal symptoms appeared before any drug abuse; If not, symptoms have to be still present after a drug-free period of 3 months (hallucinogens, amphetamines), or four weeks (cannabis).'}, 'identificationModule': {'nctId': 'NCT00204061', 'briefTitle': 'Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis', 'orgStudyIdInfo': {'id': '01 GI 9935 - P 1.1.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'supportive management', 'description': 'needs-focused, unspecific supportive management', 'interventionNames': ['Behavioral: Supportive management']}, {'type': 'EXPERIMENTAL', 'label': 'amisulpride', 'description': '24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.', 'interventionNames': ['Drug: Amisulpride']}], 'interventions': [{'name': 'Supportive management', 'type': 'BEHAVIORAL', 'otherNames': ['Clinical Management'], 'description': 'The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.', 'armGroupLabels': ['supportive management']}, {'name': 'Amisulpride', 'type': 'DRUG', 'otherNames': ['Solian'], 'description': 'Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.', 'armGroupLabels': ['amisulpride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Psychiatry and Psycotherapy University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Joachim Klosterkötter, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychiatry and Psycotherapy University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'German Research Network On Schizophrenia', 'class': 'NETWORK'}, {'name': 'Sanofi-Synthelabo', 'class': 'INDUSTRY'}, {'name': 'Department of Psychiatry University of Bonn', 'class': 'OTHER'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of the Department of Psychiatry', 'investigatorFullName': 'Stephan Ruhrmann', 'investigatorAffiliation': 'University of Cologne'}}}}