NCT00998608

Brief Summary

The purpose of this study is to compare the efficacy and safety of risperidone and risperidone plus low dose of haloperidol in the acutely schizophrenic patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

October 8, 2009

Last Update Submit

October 18, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores

    6 weeks after the initiation of antipsychotic use

Study Arms (1)

HR

EXPERIMENTAL

risperidone 2mg/d + haloperidol 2mg/d

Drug: risperidone

Interventions

risperidoneDRUG

risperidone 4mg/d

HR

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia
  • Clinical Global Impression large than 3
  • Written informed consent

You may not qualify if:

  • Comorbid of substance abuse/dependence
  • Present or history of tardive dyskinesis or neuroleptic malignant syndromes
  • Severe physical problems
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

Location

Related Publications (5)

  • Tapp A, Wood AE, Secrest L, Erdmann J, Cubberley L, Kilzieh N. Combination antipsychotic therapy in clinical practice. Psychiatr Serv. 2003 Jan;54(1):55-9. doi: 10.1176/appi.ps.54.1.55.

    PMID: 12509667RESULT

  • Centorrino F, Goren JL, Hennen J, Salvatore P, Kelleher JP, Baldessarini RJ. Multiple versus single antipsychotic agents for hospitalized psychiatric patients: case-control study of risks versus benefits. Am J Psychiatry. 2004 Apr;161(4):700-6. doi: 10.1176/appi.ajp.161.4.700.

    PMID: 15056517RESULT

  • Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. No abstract available.

    PMID: 15000267RESULT

  • Woods SW. Chlorpromazine equivalent doses for the newer atypical antipsychotics. J Clin Psychiatry. 2003 Jun;64(6):663-7. doi: 10.4088/jcp.v64n0607.

    PMID: 12823080RESULT

  • McEvoy JP, Hogarty GE, Steingard S. Optimal dose of neuroleptic in acute schizophrenia. A controlled study of the neuroleptic threshold and higher haloperidol dose. Arch Gen Psychiatry. 1991 Aug;48(8):739-45. doi: 10.1001/archpsyc.1991.01810320063009.

    PMID: 1883257RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Li-Shiu Chou, M.D.

    Kai-Suan Psychiatric Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 20, 2009

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

TW(1)