Clinical trial NCT01160679: Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
Official title: Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: anhedonic features in patients with schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 231
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of psychiatry of 25 hospitals

Brief summary: This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.


Eligibility criteria: Inclusion Criteria:

* Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
* Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I
* Patients with antipsychotic combinations (more than two agents)
* Patients who are already on any mood stabilizers and antidepressant
* Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment
* Patients who have been treated with antipsychotics in depot formulations for the last two months
* Previous enrollment or randomisation of treatment in the present NIS
* Patients who had participated in other clinical trials within 4 weeks prior to enrollment period
* Pregnant women or women who are breast-feeding

Primary outcomes:
measure: The change of total score of SHAPS
timeFrame: At baseline
measure: The change of total score of SHAPS
timeFrame: At 12 weeks
Secondary outcomes:
measure: Changes of Clinical Global Impression (CGI)-Severity score
timeFrame: At baseline
measure: Changes of Clinical Global Impression (CGI)-Severity score
timeFrame: At 12 weeks
measure: Proportion of patients having a score of 1 or 2 in CGI-I score
timeFrame: At 12 weeks
measure: Proportion of significantly improved patients in SHAPS total score (more than 30%)
timeFrame: At baseline
measure: The mean change MADRS total score
timeFrame: At baseline
measure: The mean change MADRS total score
timeFrame: At 12 weeks
measure: Proportion of significantly improved patients in SHAPS total score (more than 30%)
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Gongju-si
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Chuncheon
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Gyeongju-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Changnyeong-gun
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Department of Psychiatry
name: Sang-Woo Han, MD, PhD
role: STUDY_CHAIR
References: