Psychosis Nos/Other
Conditions
Keywords
Non Affective Psychosis, First episode, Discontinuation scheme
Brief 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.
Detailed 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.
Interventions
DRUGDiscontinuation antipsychotic treatment
Dose reduction until withdrawal
DRUGAntipsychotic treatment
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
Sponsors
Instituto de Salud Carlos III
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of relapse | 12 months | 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. |
Countries
Spain
Contacts
Primary ContactClara M. Rosso Fernández, MD
Backup ContactMiguel Ruiz Veguilla, MD, PhD
Outcome results
None listed