## Protocol Section
### Identification Module
**NCT ID:** NCT01160679

**Acronym:** PLEASURE

**Brief Title:** Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

**Official Title:** Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

#### Organization Study ID Info
**ID:** NIS-NKR-SER-2010/1
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-08-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Start Date
**Date:** 2010-08

**Status Verified Date:** 2011-08

#### Study First Post Date
**Date:** 2010-07-12
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-07
**Study First Submit QC Date:** 2010-07-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Old Name Title:** Marketing Company Medical Director

**Old Organization:** AstraZeneca

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Schizophrenia

**Keywords:**

- anhedonic features in patients with schizophrenia

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 231

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** The change of total score of SHAPS

**Time Frame:** At baseline

**Measure:** The change of total score of SHAPS

**Time Frame:** At 12 weeks

#### Secondary Outcomes

**Measure:** Changes of Clinical Global Impression (CGI)-Severity score

**Time Frame:** At baseline

**Measure:** Changes of Clinical Global Impression (CGI)-Severity score

**Time Frame:** At 12 weeks

**Measure:** Proportion of patients having a score of 1 or 2 in CGI-I score

**Time Frame:** At 12 weeks

**Measure:** Proportion of significantly improved patients in SHAPS total score (more than 30%)

**Time Frame:** At baseline

**Measure:** The mean change MADRS total score

**Time Frame:** At baseline

**Measure:** The mean change MADRS total score

**Time Frame:** At 12 weeks

**Measure:** Proportion of significantly improved patients in SHAPS total score (more than 30%)

**Time Frame:** At 12 weeks

### Eligibility Module

**Eligibility 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

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Department of psychiatry of 25 hospitals

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gongju-si

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Chungcheongnam-do

**Location 2:**

**City:** Chuncheon

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gangwon-do

**Location 3:**

**City:** Anyang-si

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeonggi-do

**Location 4:**

**City:** Bucheon

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeonggi-do

**Location 5:**

**City:** Goyang-si

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeonggi-do

**Location 6:**

**City:** Yongin-si

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeonggi-do

**Location 7:**

**City:** Gyeongju-si

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeongsangbuk-do

**Location 8:**

**City:** Changnyeong-gun

**Country:** Korea, Republic of

**Facility:** Research Site

**State:** Gyeongsangnam-do

**Location 9:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Research Site

**Location 10:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Research Site

**Location 11:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Research Site

**Location 12:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Psychiatry

**Name:** Sang-Woo Han, MD, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
