NCT00352339

Brief Summary

Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

4.3 years

First QC Date

July 13, 2006

Last Update Submit

August 3, 2009

Conditions

Schizophrenia

Keywords

SchizophreniaSwitchingEarly stageRisperidoneAripirazole

Outcome Measures

Primary Outcomes (1)

  • SANS(Scale for the Assessment of Negative Symptoms)

    12 weeks

Secondary Outcomes (3)

  • SARS(Simpson-Angus Rating Scale)

    12 weeks

  • Drug Attitude Inventory

    12 weeks

  • Side effect checklist

    12 weeks

Study Arms (3)

Aripiprazole

EXPERIMENTAL

switching group (from risperidone to aripiprazole)

Drug: Rispridoen and Aripiprazole

Risperidone

ACTIVE COMPARATOR

Start with risperidone and keep it through the end of study

Drug: Risperidne

Abilify

ACTIVE COMPARATOR

Start with aripiprazole and keep it through the end of study

Drug: Abilify

Interventions

Rispridoen and AripiprazoleDRUG

Start with risperidone and switch it to aripiprazole. Flexible dose

Aripiprazole
RisperidneDRUG

Start with risperidne and keep it through the end of study. Risperidne:flexible dose

Risperidone
AbilifyDRUG

Start with abilify and keep it through the end of study

Also known as: abilify is a generic name of aripiprazole
Abilify

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia, DSM-IV
  • Acute phase

You may not qualify if:

  • Refractory Schizophrenia
  • Substance Abuse
  • High risk for suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dongrae Hospital

Busan, 609-370, South Korea

RECRUITING

Dongseo Hospital

Masan, 630-856, South Korea

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Joo-Cheol Shim, MD,PhD

    Clinical Trial Center, Paik hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun-A Lee, MS

CONTACT

82-51-890-8955euna066@nate.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

KR(2)