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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00809731

Acronym

QTP NIS

Enrollment

490

Registered

2008-12-17

Start date

2008-12-31

Completion date

2010-09-30

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia remission status by 8-item PANSS

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Taiwan

Outcome results