Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02526030 |
Date of registration:
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12/08/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up
PAFIP2_3Y |
Scientific title:
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Phase IV Study of Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II): a 3-year Follow-up |
Date of first enrolment:
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October 2008 |
Target sample size:
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203 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02526030 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Benedicto Crespo-Facorro, Professor |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Santander, Spain. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP II) from
October 2005 to January 2011.
Exclusion Criteria:
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
criteria for drug dependence
- Meeting DSM-IV criteria for mental retardation
- Having a history of neurological disease or head injury.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psychotic Disorders
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Schizophrenia
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Intervention(s)
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Drug: Aripiprazole
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Drug: Quetiapine
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Drug: Ziprasidone
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Primary Outcome(s)
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Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment)
[Time Frame: 3 years]
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Secondary Outcome(s)
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Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS)
[Time Frame: 3 years]
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Change in general psychopathology measured by the Brief Psychiatric Rating Scale (BPRS)
[Time Frame: 3 years]
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Functional outcome measured by Disability Assessment Scale (DAS) and Global Assessment Functioning (GAF).
[Time Frame: 3 years]
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Adherence to treatment measured by Morinsky questionnaire
[Time Frame: 3 years]
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Secondary ID(s)
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AZQ2005_3Y
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CI 2005-0308007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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