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Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia (PLEASURE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01160679
First received: July 7, 2010
Last updated: August 17, 2011
Last verified: August 2011
History of Changes

July 7, 2010
August 17, 2011
August 2010
August 2011   (final data collection date for primary outcome measure)
  • The change of total score of SHAPS [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • The change of total score of SHAPS [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01160679 on ClinicalTrials.gov Archive Site
  • Changes of Clinical Global Impression (CGI)-Severity score [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Changes of Clinical Global Impression (CGI)-Severity score [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients having a score of 1 or 2 in CGI-I score [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of significantly improved patients in SHAPS total score (more than 30%) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • The mean change MADRS total score [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • The mean change MADRS total score [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of significantly improved patients in SHAPS total score (more than 30%) [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Department of psychiatry of 25 hospitals
Schizophrenia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01160679
NIS-NKR-SER-2010/1
No
Marketing Company Medical Director, AstraZeneca
AstraZeneca
Not Provided
Study Chair: Sang-Woo Han, MD, PhD Department of Psychiatry
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP