10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP_10Y)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03090490|
Recruitment Status : Enrolling by invitation
First Posted : March 24, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders||Other: Antipsychotic treatment discontinuation Other: Maintenance treatment discontinuation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 10-year Follow-up|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
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 treatment discontinuation
Maintenance antipsychotic medication to stabilized patients
- Relapse rate [ Time Frame: At 10 years ]The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
- Change in general psychopathology measured by BPRS [ Time Frame: At 10 years ]Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
- Change in overall clinical status measured by CGI [ Time Frame: At 10 years ]Measured by changes in total score of the Clinical Global Impression (CGI).
- Change in negative symptoms measured by SANS [ Time Frame: At 10 years ]Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).
- Change in negative symptoms measured by SAPS [ Time Frame: At 10 years ]Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).
- Time to relapse [ Time Frame: At 10 years ]Time to relapse in the two groups of patients, discontinuation and maintenance.
- Functionality status measured by DAS [ Time Frame: At 10 years ]Measured by changes in total score of the Disability Assessment Scale (DAS).
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): NCT03090490
|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|