3-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 three 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 3-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 antipsychotic treatment


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 antipsychotic treatment<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 main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. | At 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 years. | 
| Time to relapse. | Time to relapse in the two groups of patients, discontinuation and maintenance. | At 3 years. | 
| Clinical functionality. |  | At 3 years. | 

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