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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02220504 |
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Date of registration:
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13/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
ADARFEP |
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Scientific title:
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Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02220504 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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 |
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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, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the
University Hospital Marqués de Valdecilla (Santander, Spain).
- A minimum of 18 months on antipsychotic treatment.
- Meeting clinical remission criteria for at least the 12 months prior to inclusion.
- Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
- Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.
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:
15 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia Spectrum and Other Psychotic Disorders
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Schizophrenia Relapse
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Schizophrenia
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Intervention(s)
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Other: Maintenance antipsychotic treatment
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Other: Antipsychotic treatment discontinuation
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Primary Outcome(s)
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Relapse rate.
[Time Frame: At 3 years.]
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Secondary Outcome(s)
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Clinical psychopathology.
[Time Frame: At 3 years.]
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Clinical functionality.
[Time Frame: At 3 years.]
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Time to relapse.
[Time Frame: At 3 years.]
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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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