Efficacy and Safety of Aripiprazole in First Episode Psychosis

Efficacy and Safety of Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

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

Study Overview

• Status: Completed
• Conditions: First Episode Psychosis
• Intervention / Treatment: Drug: Aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chunchon, Korea, Republic of
    • Department of Psychiatry, Kangwon National University College of Medicine
  • Daegu, Korea, Republic of
    • Department of Psychiatry, Kyungpook national University School of Medicine
  • Daejeon, Korea, Republic of
    • Department of Psychiatry, Eulji University, School of Medicine
  • Gongju, Korea, Republic of
    • Department of Psychiatry, Kongju National Hospital
  • Goyang, Korea, Republic of
    • Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital
  • Hwasun, Korea, Republic of
    • Department of Psychiatry, Chonnam National University Medical School
  • Iksan, Korea, Republic of
    • Department of Psychiatry, College of Medicine, Won-Kwang University
  • Incheon, Korea, Republic of
    • Department of Psychiatry, Gachon University of Medicine and Science
  • Jeonju, Korea, Republic of, 561-712
    • Department of Psychiatry, Chonbuk National University Hospital
  • Koyang, Korea, Republic of
    • Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine
  • Kwangju, Korea, Republic of
    • St. John of God Neuropsychiatric Hospital
  • Pusan, Korea, Republic of
    • department of Neuropsychiatry. Dong-Eui University Medical Center
  • Seoul, Korea, Republic of
    • Department of Neuropsychiatry, Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 1
Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 2
Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 3
Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 4
Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS	week 2
Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS	week 4
Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS	week 1
Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile	week 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): February 13, 2012
• Last Update Submitted That Met QC Criteria: February 9, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: CBIRB0909-97