Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment

Study Overview
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Brief Summary
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The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.

Official Title
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A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia) Male or female aged between 18 and 65 years Patients recruited from both in-patient and out-patient clinics Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate Exclusion Criteria: Pregnancy or lactation Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Group<br>All commercially available 2nd-generation antipsychotic with an indication of treating schizophrenia will be prescribed by the physician according to normal practices | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-Severity of illness (CGI-SI) |  | Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-Degree of change (CGI-DC) |  | Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) | 
| MADRS, GAF, DIEPSS |  | Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) | 
| Remission status |  | Visit 1(Day 0), 5(Week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia remission status by 8-item PANSS