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
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 231
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Department of psychiatry of 25 hospitals

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160679

Locations
Korea, Republic of
Research Site
Gongju-si, Chungcheongnam-do, Korea, Republic of
Research Site
Chuncheon, Gangwon-do, Korea, Republic of
Research Site
Anyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Bucheon, Gyeonggi-do, Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Yongin-si, Gyeonggi-do, Korea, Republic of
Research Site
Gyeongju-si, Gyeongsangbuk-do, Korea, Republic of
Research Site
Changnyeong-gun, Gyeongsangnam-do, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Daejeon, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Sang-Woo Han, MD, PhD Department of Psychiatry
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01160679     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2010/1
Study First Received: July 7, 2010
Last Updated: August 17, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
anhedonic features in patients with schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 25, 2014