Efficacy and Safety of Aripiprazole in First Episode Psychosis

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01026584
• Collaborator: Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
• Enrollment: 55
• Locations: 13
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the efficacy and safety of aripiprazole in patients with first episode psychosis.

Condition or Disease	Intervention/Treatment	Phase
First Episode Psychosis	Drug: Aripiprazole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: drug	Drug: Aripiprazole; 6 week prospective study

Outcome Measures

Primary Outcome Measures

1. Symptoms assessment by objective rating scales [week 1]

   PANSS total score, SANS, CGI

2. Symptoms assessment by objective rating scales [week 2]

   PANSS total score, SANS, CGI

3. Symptoms assessment by objective rating scales [week 3]

   PANSS total score, SANS, CGI

4. Symptoms assessment by objective rating scales [week 4]

   PANSS total score, SANS, CGI

5. Symptoms assessment by objective rating scales [week 6]

   PANSS total score, SANS, CGI

Secondary Outcome Measures

1. Assessment of adverse events by objective rating scales and self report scales [week 1]

   NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

2. Assessment of adverse events by objective rating scales and self report scales [week 2]

   NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

3. Assessment of adverse events by objective rating scales and self report scales [week 4]

   NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS

4. Assessment of adverse events by objective rating scales and self report scales [week 6]

   NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.

Exclusion Criteria:

• Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence

• Needing another nonantipsychotic psychotropic medication at enrollment

• Having a serious or unstable medical illness.

• Pregnant or lactating women or women without adequate contraception will be also excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Kangwon National University College of Medicine	Chunchon		Korea, Republic of
2	Department of Psychiatry, Kyungpook national University School of Medicine	Daegu		Korea, Republic of
3	Department of Psychiatry, Eulji University, School of Medicine	Daejeon		Korea, Republic of
4	Department of Psychiatry, Kongju National Hospital	Gongju		Korea, Republic of
5	Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital	Goyang		Korea, Republic of
6	Department of Psychiatry, Chonnam National University Medical School	Hwasun		Korea, Republic of
7	Department of Psychiatry, College of Medicine, Won-Kwang University	Iksan		Korea, Republic of
8	Department of Psychiatry, Gachon University of Medicine and Science	Incheon		Korea, Republic of
9	Department of Psychiatry, Chonbuk national University Hospital	Jeonju		Korea, Republic of	561-712
10	Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine	Koyang		Korea, Republic of
11	St. John of God Neuropsychiatric Hospital	Kwangju		Korea, Republic of
12	department of Neuropsychiatry. Dong-Eui University Medical Center	Pusan		Korea, Republic of
13	Department of Neuropsychiatry, Soonchunhyang University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chonbuk National University Hospital
• Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT01026584
• Other Study ID Numbers: CBIRB0909-97
• First Posted: Dec 4, 2009
• Last Update Posted: Feb 13, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Psychotic Disorders; Mental Disorders; Aripiprazole

Study Results

No Results Posted as of Feb 13, 2012