First-episodes of non-affective psychosis. MedDRA version: 14.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10038631 Term: Residual schizophrenia, in remission System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10065155 Term: Treatment withdrawal System Organ Class: 10042613 - Surgical and
Conditions
Interventions
Pharmaceutical Form: Tablet and powder for oral solution
INN or Proposed INN: LEVOMEPROMAZINE
CAS Number: 60-99-1
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10
Sponsors
Fundacion Progreso y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult age 18 to 55 years old - Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis 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 - Shows remission criteria (Van Os y cols., 2006) - Signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Not fluent in Spanish - Takes mood stabilizers (Lithium, antiepileptic drugs...) - Dependency on alcohol or other substances of abuse (cannabis, cocaíne...) - History of Craneo-encephalic Trauma with loss of consciousness for more than 1 hour, stroke or other CNS disorders - IQ less than 70 - Suicide attempt from stabilization - Pregnancy or planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that patients with a first episode of non-affective psychosis, who have followed antipsychotic treatment for 12 months, who already show remission criteria, and who continue with antipsychotic treatment for 12 more months, show the same risk of relapse (measured by PANSS and ICG) that patients with the same medical condition who follow a discontinuation treatment scheme based in the presence of prodromes;Secondary Objective: 1. To evaluate the differences among the two treatment arms, after 12 months from the intervention, in cognitive performance, level of functioning (WHO-DAS, performance at work/school), life quality or readmission. 2. To identify at the time of intervention the clinical charasteristics, functional recovery status, and cognitive features of patients that will benefit from the therapeutic strategy of discontinuation.;Primary end point(s): Clinical relapse (measured by PANSS and ICG);Timepoint(s) of evaluation of this end point: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Readmission, quality of life, cognitive functioning, weight, side effects and clinical course.;Timepoint(s) of evaluation of this end point: 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. | — |
Countries
Spain
Contacts
Public ContactClara María Rosso Fernández
UCICEC-Hospital Universitario Virgen del Rocio
Outcome results
None listed