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

NCT01765829 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-12-05

No results posted yet for this study

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.

Conditions

  • Psychosis Nos/Other

Interventions

DRUG

Discontinuation antipsychotic treatment

Dose reduction until withdrawal

DRUG

Antipsychotic treatment

Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Miguel Ruiz Veguilla, MD, PhD · Virgen del Rocío Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01765829 on ClinicalTrials.gov