SchizophreniaPLEASURENCT01160679
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 12 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 231 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Aug 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of psychiatry of 25 hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Research Site
Anyang-si, Gyeonggi-do
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan, Busan
Research Site
Changnyeong, Gyeongsangnam-do
Research Site
Chuncheon, Gangwon-do
Research Site
Daegu, Daegu
Research Site
Daejeon, Daejeon
Research Site
Gongju, Chungcheongnam-do
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gyeongju, Gyeongsangbuk-do
Research Site
Seoul, Seoul
Research Site
Yongin-si, Gyeonggi-do
About this study
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.
- Conditions
- Schizophrenia
- Keywords
- anhedonic features in patients with schizophrenia
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of total score of SHAPS
Measured: At baseline
The change of total score of SHAPS
Measured: At 12 weeks
Secondary outcomes (7)
Changes of Clinical Global Impression (CGI)-Severity score
Measured: At baseline
Changes of Clinical Global Impression (CGI)-Severity score
Measured: At 12 weeks
Proportion of patients having a score of 1 or 2 in CGI-I score
Measured: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Measured: At baseline
The mean change MADRS total score
Measured: At baseline
The mean change MADRS total score
Measured: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sang-Woo Han, MD, PhD, Study chair, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160679
- Sponsor's protocol ID
- NIS-NKR-SER-2010/1
- Acronym
- PLEASURE
- Status last verified
- Aug 2011
- First submitted
- 7 Jul 2010
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01160679
- Acronym / sponsor ID
- PLEASURE / NIS-NKR-SER-2010/1
- Conditions
- Schizophrenia
- Keywords
- anhedonic features in patients with schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of psychiatry of 25 hospitals
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of total score of SHAPS
Time frame: At baseline
The change of total score of SHAPS
Time frame: At 12 weeks
7 secondary outcomes
Changes of Clinical Global Impression (CGI)-Severity score
Time frame: At baseline
Changes of Clinical Global Impression (CGI)-Severity score
Time frame: At 12 weeks
Proportion of patients having a score of 1 or 2 in CGI-I score
Time frame: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Time frame: At baseline
The mean change MADRS total score
Time frame: At baseline
The mean change MADRS total score
Time frame: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Time frame: At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Woo Han, MD, PhD study chair
Department of Psychiatry
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of total score of SHAPS (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.