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Trial NCT00000374

Resource URI: http://static.linkedct.org/resource/trials/NCT00000374
linkedct:brief_title Treatment for First-Episode Schizophrenia
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8234>
linkedct:condition <http://static.linkedct.org/resource/condition/11790>
linkedct:criteria Inclusion Criteria: - First episode schizophrenia, schizophreniform disorder or schizoaffective disorder Exclusion Criteria: - Prior treatment with antipsychotic medications.
linkedct:description The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone. Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another. First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00320671
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 40 Years
linkedct:eligibility_minimum_age 16 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:has_dmc Yes
linkedct:id NCT00000374
rdfs:label Trial NCT00000374
linkedct:lastchanged_date February 19, 2009
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/154384>
linkedct:location <http://static.linkedct.org/resource/location/154894>
linkedct:nct_id NCT00000374
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Preventing Morbidity in First-Episode Schizophrenia
linkedct:org_study_id R01 MH060004-01
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/13446>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000374>
linkedct:phase Phase 4
linkedct:secondary_id DSIR 83-ATAP
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date September 1998
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
rdf:type linkedct:trials
linkedct:verification_date February 2009