Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Keywords
Treatment, Maintenance
Brief summary
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
Interventions
Withdrawal of antipsychotic medication to stabilized patients.
OTHERMaintenance antipsychotic treatment
Maintenance antipsychotic medication to stabilized patients.
Sponsors
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Fundación Marques de Valdecilla
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain). * A minimum of 18 months on antipsychotic treatment. * Meeting clinical remission criteria for at least the 12 months prior to inclusion. * Meeting the functional recovery criteria for at least the 6 months prior to inclusion. * Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.
Exclusion criteria
* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence. * Meeting DSM-IV criteria for mental retardation. * Having a history of neurological disease or head injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate. | At 3 years. | The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical psychopathology. | At 3 years. | Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores. |
| Time to relapse. | At 3 years. | Time to relapse in the two groups of patients, discontinuation and maintenance. |
| Clinical functionality. | At 3 years. | — |
Countries
Spain
Outcome results
None listed