Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01160679

Acronym

PLEASURE

Enrollment

231

Registered

2010-07-12

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2011-08-18

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

Conditions

Schizophrenia

Keywords

anhedonic features in patients with schizophrenia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The change of total score of SHAPS	At baseline

Secondary

Measure	Time frame
Changes of Clinical Global Impression (CGI)-Severity score	At baseline
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 baseline
The mean change MADRS total score	At baseline

Countries

South Korea

Outcome results