Back to results3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP)
Primary Purpose
Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Antipsychotic treatment discontinuation
Maintenance antipsychotic treatment
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 main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Secondary Outcome Measures
Clinical psychopathology.
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 to relapse in the two groups of patients, discontinuation and maintenance.
Clinical functionality.
Full Information
NCT ID
NCT02220504
First Posted
August 13, 2014
Last Updated
March 13, 2017
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
NCT02220504
Brief Title
3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Acronym
ADARFEP
Official Title
Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
July 2014 (Actual)
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 three 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 (Actual)
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 antipsychotic treatment
Intervention Description
Maintenance antipsychotic medication to stabilized patients.
Primary Outcome Measure Information:
Title
Relapse rate.
Description
The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Time Frame
At 3 years.
Secondary Outcome Measure Information:
Title
Clinical psychopathology.
Description
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 Frame
At 3 years.
Title
Time to relapse.
Description
Time to relapse in the two groups of patients, discontinuation and maintenance.
Time Frame
At 3 years.
Title
Clinical functionality.
Time Frame
At 3 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
Citations:
PubMed Identifier
26759992
Citation
Mayoral-van Son J, de la Foz VO, Martinez-Garcia O, Moreno T, Parrilla-Escobar M, Valdizan EM, Crespo-Facorro B. Clinical outcome after antipsychotic treatment discontinuation in functionally recovered first-episode nonaffective psychosis individuals: a 3-year naturalistic follow-up study. J Clin Psychiatry. 2016 Apr;77(4):492-500. doi: 10.4088/JCP.14m09540.
Results Reference
derived
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3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
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