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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Changhua, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

CGI-Severity of illness (CGI-SI)

Time frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)

Secondary outcomes

CGI-Degree of change (CGI-DC)

Time frame: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
MADRS, GAF, DIEPSS

Time frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Remission status

Time frame: Visit 1(Day 0), 5(Week 4)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: QTP NIS

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Dec 17, 2008
Registry last updated: Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed