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

Fundación Pública Andaluza Progreso y Salud

Status and phase: Unknown; Phase 3

Conditions: Psychosis Nos/Other

Treatments: Drug: Antipsychotic treatment; Drug: Discontinuation antipsychotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01765829

NONSTOP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Antipsychotic treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Antipsychotic treatment

Discontinuation antipsychotic treatment

Experimental group

Description:

Dose reduction of antipsychotic treatment (25% every 4 weeks).

Treatment:

Drug: Discontinuation antipsychotic treatment