Back to results10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP_10Y)
Primary Purpose
Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Antipsychotic treatment discontinuation
Maintenance treatment discontinuation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Treatment, Maintenance
Eligibility Criteria
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.
Sites / Locations
- University Hospital Marques de Valdecilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Antipsychotic treatment discontinuation (DT)
Maintenance antipsychotic treatment (MT)
Outcomes
Primary Outcome Measures
Relapse rate
The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Secondary Outcome Measures
Change in general psychopathology measured by BPRS
Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
Change in overall clinical status measured by CGI
Measured by changes in total score of the Clinical Global Impression (CGI).
Change in negative symptoms measured by SANS
Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).
Change in negative symptoms measured by SAPS
Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).
Time to relapse
Time to relapse in the two groups of patients, discontinuation and maintenance.
Functionality status measured by DAS
Measured by changes in total score of the Disability Assessment Scale (DAS).
Full Information
NCT ID
NCT03090490
First Posted
March 14, 2017
Last Updated
January 13, 2020
Sponsor
Fundación Marques de Valdecilla
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
1. Study Identification
Unique Protocol Identification Number
NCT03090490
Brief Title
10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Acronym
ADARFEP_10Y
Official Title
Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Marques de Valdecilla
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
Keywords
Treatment, Maintenance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Antipsychotic treatment discontinuation (DT)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Maintenance antipsychotic treatment (MT)
Intervention Type
Other
Intervention Name(s)
Antipsychotic treatment discontinuation
Intervention Description
Withdrawal of antipsychotic medication to stabilized patients
Intervention Type
Other
Intervention Name(s)
Maintenance treatment discontinuation
Intervention Description
Maintenance antipsychotic medication to stabilized patients
Primary Outcome Measure Information:
Title
Relapse rate
Description
The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Time Frame
At 10 years
Secondary Outcome Measure Information:
Title
Change in general psychopathology measured by BPRS
Description
Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
Time Frame
At 10 years
Title
Change in overall clinical status measured by CGI
Description
Measured by changes in total score of the Clinical Global Impression (CGI).
Time Frame
At 10 years
Title
Change in negative symptoms measured by SANS
Description
Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).
Time Frame
At 10 years
Title
Change in negative symptoms measured by SAPS
Description
Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).
Time Frame
At 10 years
Title
Time to relapse
Description
Time to relapse in the two groups of patients, discontinuation and maintenance.
Time Frame
At 10 years
Title
Functionality status measured by DAS
Description
Measured by changes in total score of the Disability Assessment Scale (DAS).
Time Frame
At 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo-Facorro, Professor
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
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