10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up

Conditions
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Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders

Intervention / Treatment
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* Other: Antipsychotic treatment discontinuation
* Other: Maintenance treatment discontinuation


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Antipsychotic treatment discontinuation (DT) | Other: Antipsychotic treatment discontinuation<br>* Withdrawal of antipsychotic medication to stabilized patients<br>|
| Active Comparator: Control group<br>Maintenance antipsychotic treatment (MT) | Other: Maintenance treatment discontinuation<br>* Maintenance antipsychotic medication to stabilized patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate | The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. | At 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general psychopathology measured by BPRS | Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS). | At 10 years | 
| Change in overall clinical status measured by CGI | Measured by changes in total score of the Clinical Global Impression (CGI). | At 10 years | 
| Change in negative symptoms measured by SANS | Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS). | At 10 years | 
| Change in negative symptoms measured by SAPS | Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS). | At 10 years | 
| Time to relapse | Time to relapse in the two groups of patients, discontinuation and maintenance. | At 10 years | 
| Functionality status measured by DAS | Measured by changes in total score of the Disability Assessment Scale (DAS). | At 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Maintenance