Efficacy and Safety of Aripiprazole in First Episode Psychosis

Phase 4

Completed

• Conditions: First Episode Psychosis
• Interventions: Drug: Aripiprazole

• Registration Number: NCT01026584
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
drug	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Symptoms assessment by objective rating scales	week 6	PANSS total score, SANS, CGI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Department of Psychiatry, Kangwon National University College of Medicine; 🇰🇷 Chunchon, Korea, Republic of

Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

Department of Psychiatry, Kyungpook national University School of Medicine; 🇰🇷 Daegu, Korea, Republic of

Department of Psychiatry, Eulji University, School of Medicine; 🇰🇷 Daejeon, Korea, Republic of

Department of Psychiatry, Kongju National Hospital; 🇰🇷 Gongju, Korea, Republic of

Department of Psychiatry, Chonbuk national University Hospital; 🇰🇷 Jeonju, Korea, Republic of

department of Neuropsychiatry. Dong-Eui University Medical Center; 🇰🇷 Pusan, Korea, Republic of

Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine; 🇰🇷 Koyang, Korea, Republic of

Department of Psychiatry, Chonnam National University Medical School; 🇰🇷 Hwasun, Korea, Republic of

Department of Psychiatry, College of Medicine, Won-Kwang University; 🇰🇷 Iksan, Korea, Republic of

Department of Psychiatry, Gachon University of Medicine and Science; 🇰🇷 Incheon, Korea, Republic of

St. John of God Neuropsychiatric Hospital; 🇰🇷 Kwangju, Korea, Republic of

Department of Neuropsychiatry, Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of