Experimental study in humans to evaluate the efficacy of continual treatment compared to discontinuation based in the presence of early symthoms in a first episode of non-affective psychosis.

Phase 1

• Conditions: First-episodes of non-affective psychosis.; MedDRA version: 14.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: LLTClassification code 10038631Term: Residual schizophrenia, in remissionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: LLTClassification code 10065155Term: Treatment withdrawalSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2011-004826-87-ES
• Lead Sponsor: Fundacion Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-28
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified