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OpenTrials
Completed

NCT Number: NCT01160679

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The change of total score of SHAPS

    Time frame: At baseline

  2. The change of total score of SHAPS

    Time frame: At 12 weeks

Secondary outcomes

  1. Changes of Clinical Global Impression (CGI)-Severity score

    Time frame: At baseline

  2. Changes of Clinical Global Impression (CGI)-Severity score

    Time frame: At 12 weeks

  3. Proportion of patients having a score of 1 or 2 in CGI-I score

    Time frame: At 12 weeks

  4. Proportion of significantly improved patients in SHAPS total score (more than 30%)

    Time frame: At baseline

  5. The mean change MADRS total score

    Time frame: At baseline

  6. The mean change MADRS total score

    Time frame: At 12 weeks

  7. Proportion of significantly improved patients in SHAPS total score (more than 30%)

    Time frame: At 12 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: PLEASURE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2010
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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