Clinical trial NCT00809731: Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment
Official title: A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia remission status by 8-item PANSS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: CGI-Severity of illness (CGI-SI)
timeFrame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Secondary outcomes:
measure: CGI-Degree of change (CGI-DC)
timeFrame: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
measure: MADRS, GAF, DIEPSS
timeFrame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
measure: Remission status
timeFrame: Visit 1(Day 0), 5(Week 4)
Other outcomes:
Locations:
city: Changhua-Lugang
country: Taiwan
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Kaohsiung-Niosong
country: Taiwan
facility: Research Site
city: Kaohsiung-Sanmin
country: Taiwan
facility: Research Site
city: Kaohsiung-Yanchao
country: Taiwan
facility: Research Site
city: Keelung
country: Taiwan
facility: Research Site
city: Miaoli-Toufen
country: Taiwan
facility: Research Site
city: Miaoli
country: Taiwan
facility: Research Site
city: Taichung-Beitun
country: Taiwan
facility: Research Site
city: Taichung-Shalu
country: Taiwan
facility: Research Site
city: Taipei-Banciao
country: Taiwan
facility: Research Site
city: Taipei-Datong
country: Taiwan
facility: Research Site
city: Taipei-Shilin
country: Taiwan
facility: Research Site
city: Taipei-Shipai
country: Taiwan
facility: Research Site
city: Taipei-Xindian
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yuan-Hwa Chou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: