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

• Status: Unknown status
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud
• Collaborator: Instituto de Salud Carlos III
• Treatments: Amisulpride; Antipsychotic Agents; Aripiprazole; Asenapine; Chlorpromazine; Clopenthixol; Clothiapine; Clozapine; Droperidol; Flupenthixol; Flupenthixol decanoate; Haloperidol; Haloperidol decanoate; Methotrimeprazine; Olanzapine; Paliperidone Palmitate; Perphenazine; Pimozide; Quetiapine Fumarate; Risperidone; Sertindole; Sulpiride; Sultopride; Tiapride Hydrochloride; Trifluoperazine; Ziprasidone

Criteria

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.