3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP)
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|ClinicalTrials.gov Identifier: NCT02220504|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders||Other: Antipsychotic treatment discontinuation Other: Maintenance antipsychotic treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up|
|Actual Study Start Date :||July 2004|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Intervention group
Antipsychotic treatment discontinuation (DT)
Other: Antipsychotic treatment discontinuation
Withdrawal of antipsychotic medication to stabilized patients.
Active Comparator: Control group
Maintenance antipsychotic treatment (MT)
Other: Maintenance antipsychotic treatment
Maintenance antipsychotic medication to stabilized patients.
- Relapse rate. [ Time Frame: At 3 years. ]The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
- Clinical psychopathology. [ Time Frame: At 3 years. ]Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores.
- Time to relapse. [ Time Frame: At 3 years. ]Time to relapse in the two groups of patients, discontinuation and maintenance.
- Clinical functionality. [ Time Frame: At 3 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220504
|University Hospital Marques de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Principal Investigator:||Benedicto Crespo-Facorro, Professor||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|