Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis

Study Overview
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Brief Summary
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The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.

Detailed Description
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Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age range: 18 - 55 years of both sex. Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.

Official Title
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Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis.

Conditions
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Psychosis Nos/Other

Intervention / Treatment
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* Drug: Discontinuation antipsychotic treatment
* Drug: Antipsychotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult age from 18 to 55 years old Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Antipsychotic treatment for 12 months since clinical stabilization. Clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family. No changes in the antipsychotic doses in the last 4 months. No suicide attempts in the last 12 months. Patient who shows remission criteria. Signed informed consent form. Exclusion Criteria: Patient who is not fluent in Spanish language Patient who takes mood stabilizers (Lithium, antiepileptic drugs...) Dependency on alcohol or other substances of abuse (cannabis, cocaine...) History of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders. Intelligence testing (IQ) less than 70. Suicide attempt from stabilization. Pregnancy or planning to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antipsychotic treatment<br>Antipsychotic treatment according to common clinical practice Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine, Pipotiazine, Flufenazine, Periciazine, Clozapine, Pimozide, Perfenazine, Sertindole, Levomepromazine, Amisulpride, Asenapine, Tiapride, Droperidol, Ziprasidone. | Drug: Antipsychotic treatment<br>* Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice<br>* Other names: Antipsychotic drugs;|
| Experimental: Discontinuation antipsychotic treatment<br>Dose reduction of antipsychotic treatment (25% every 4 weeks). | Drug: Discontinuation antipsychotic treatment<br>* Dose reduction until withdrawal<br>* Other names: Ziprasidone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of relapse | The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Affective Psychosis, First episode, Discontinuation scheme