Refractory Schizophrenia Clinical Trial
Official title:
Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia
Primary Objective:
Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in
improving executive functions in patients with refractory schizophrenia as measured by the
BADS.
Secondary Objectives: improvement of functional aspects,basic and instrumental activities of
daily living,negative symptoms and cognitive functions improvement
Hypothesis: OT is more effective than control group to improve executive functions in
patients with refractory schizophrenia.
A single-center, randomized, single blind, controlled study, lasting one year, including the
follow-up.
The study is conducted in two groups:the experimental group is based on the OGI method (N=30
patients) and the control group receives craft activities (N = 30 patients).
Psychiatric, neuropsychological and functional aspects are assessed at the beginning, after
30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative
Syndrome Scale) is used for monitoring psychopathological symptoms during the study.
Scales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and
basic and instrumental activities of daily living. The neuropsychological evaluation
includes a battery to measure attention, executive functions, memory and estimated
intellectual efficiency.
Statistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are
also calculated to messure clinical efficacy, effect size and needed number to treat.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04302636 -
The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia
|
N/A | |
| Recruiting |
NCT04352569 -
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
| Recruiting |
NCT03094429 -
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
|
Phase 2/Phase 3 | |
| Completed |
NCT02377505 -
Deep Brain Stimulation in Treatment Resistant Schizophrenia
|
N/A | |
| Recruiting |
NCT02049021 -
Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia
|
Phase 4 | |
| Completed |
NCT01386918 -
Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
|
N/A |