Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026584
Other study ID # CBIRB0909-97
Secondary ID
Status Completed
Phase Phase 4
First received December 3, 2009
Last updated February 9, 2012
Start date October 2009
Est. completion date February 2012

Study information

Verified date February 2012
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority Republic of Korea: Chonbuk National University Hospital Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 59 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Aripiprazole
6 week prospective study

Locations

Country Name City State
Korea, Republic of Department of Psychiatry, Kangwon National University College of Medicine Chunchon
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, Inje University College of Medicine, Ilsan Paik Hospital Goyang
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 Department of Psychiatry, Chonbuk national University Hospital Jeonju
Korea, Republic of Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine Koyang
Korea, Republic of St. John of God Neuropsychiatric Hospital Kwangju
Korea, Republic of department of Neuropsychiatry. Dong-Eui University Medical Center Pusan
Korea, Republic of Department of Neuropsychiatry, Soonchunhyang University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Chonbuk National University Hospital Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, CGI week 1 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, CGI week 2 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, CGI week 3 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, CGI week 4 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, CGI week 6 No
Secondary Assessment of adverse events by objective rating scales and self report scales NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS week 1 Yes
Secondary Assessment of adverse events by objective rating scales and self report scales NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS week 2 Yes
Secondary Assessment of adverse events by objective rating scales and self report scales NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS week 4 Yes
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Completed NCT00202280 - Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication Phase 2/Phase 3
Completed NCT03983421 - Feasibility of an Early Detection Program for Early Psychosis on a College Campus
Recruiting NCT04046497 - Artificial Intelligence to Measure Adherence to Oral Medication Phase 4
Withdrawn NCT04369677 - Thermoregulation Among Individuals With First-episode Psychosis
Completed NCT03568500 - A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic Phase 4
Completed NCT03102151 - Reducing the Duration of Untreated Psychosis
Completed NCT00916461 - Role of Minocycline in First Episode Psychosis Phase 1/Phase 2
Recruiting NCT05310838 - Optimizing Engagement in Services for First-Episode Psychosis N/A
Completed NCT03501160 - Socially Inappropriate Behaviour in People With First Episode Psychosis: A Caregivers' Perspective
Recruiting NCT03196128 - Early Intervention Psychosis Communication and Engagement Trial N/A
Recruiting NCT04005378 - Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs Phase 4
Recruiting NCT03919760 - Early Psychosis Intervention - Spreading Evidence-based Treatment
Completed NCT03409393 - Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis N/A
Completed NCT01753284 - First Episode Psychosis and Pathway to Care in Nordland
Completed NCT01157585 - Efficacy and Safety of Paliperidone ER in First Episode Psychosis Phase 4
Completed NCT05737966 - Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
Recruiting NCT04021719 - OnTrackNY's Learning Healthcare System
Recruiting NCT04889911 - Pilot RCT of Self-stigma Treatment for First Episode Psychosis N/A
Recruiting NCT04853485 - Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes N/A