NCT01160679
Completed
Not Applicable
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
ConditionsSchizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- AstraZeneca
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- The change of total score of SHAPS
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The change of total score of SHAPS
Time Frame: At 12 weeks
Secondary Outcomes
- Proportion of patients having a score of 1 or 2 in CGI-I score(At 12 weeks)
- Proportion of significantly improved patients in SHAPS total score (more than 30%)(At 12 weeks)
- Changes of Clinical Global Impression (CGI)-Severity score(At 12 weeks)
- The mean change MADRS total score(At 12 weeks)
Study Sites (1)
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