NCT00202007

Brief Summary

This study design is subject to relevant SFDA regulations about clinical trials. Patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). After screening and washout period, eligible patients will be randomly assigned to the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will be hospitalized for the entire duration of the study. Patients' condition will be assessed weekly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 1, 2023

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 30, 2023

Conditions

Schizophrenia

Keywords

AripiprazoleSchizophreniaClinical trialRisperidone

Outcome Measures

Primary Outcomes (1)

  • Deduction rate of PANSS total

Secondary Outcomes (4)

  • PANSS positive

  • PANSS negative

  • CGI

  • CGI improvement

Interventions

Aripiprazole tablet, 5-30mg/day, oral, 6 weeksDRUG
Risperidone tablet, 1-6mg/day, oral, 6 weeksDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia or Acute schizophrenia-like psychotic disorder(ICD 10)
  • PANSS total of no less than 60
  • Age: 18-65; male or female
  • PANSS total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; No washout is needed for patients who had never taken any antipsychotics before; In cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.No serious function impairment in heart, liver or kidney.

You may not qualify if:

  • For screening
  • Tendency or history of suicide
  • Patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment
  • Diagnosis of other mental diseases besides Schizophrenia
  • Diabetes or other serious unstable diseases or the following neurological diseases, migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and TIA etc
  • Patients who take Fluoxetine in the past 1-month before screening
  • Patients who had participated any other clinical trial in the past 1-month before screening
  • History of alcohol or drug abuse or dependence
  • Pregnancy or breast-feeding
  • Patients who have had gastrointestinal operations that could affect drug absorption.
  • Allergy to Risperidone or Aripiprazole or hypersensitiveness to any drug
  • Patients who discontinued long-acting antipsychotics less than one treatment cycle before screening
  • Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course, or patients who did not respond to Clozapine
  • Patients who had Electroconvulsive Therapy (ECT) in the past 6 months After washout
  • \. Diagnosis of other mental diseases besides schizophrenia during the washout period 2. Significant abnormal ECG or laboratory examination results (ALT,AST\>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Location

Psychiatry Dept. People's Hospital, Wuhan University

Wuhan, Hubei, China

Location

Mental Health Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Anding Hosp. Capital University of Medical Science

Beijing, China

Location

Institute of Mental Health, Peking University

Beijing, China

Location

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

AripiprazoleRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Liang Shu, Professor

    Institute of Mental Health, Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2005

Study Completion

July 1, 2005

Last Updated

November 1, 2023

Record last verified: 2005-09

Locations

CN(6)