Comparison of the Efficacy and Safety of Risperidone Versus Risperidone Plus Low Dose of Haloperidol in the Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind, Comparison of the Efficacy and Safety of Risperidone Versus Risperidone Combined With Low Dose of Haloperidol in the Treatment of Schizophrenic Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00998608
• Other study ID #: KSPH-2007-17
• Status: Terminated
• Phase: Phase 4
• First received: October 8, 2009
• Last updated: October 18, 2009
• Start date: August 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Kaohsiung Kai-Suan Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia. Surveys have shown that antipsychotic drug combinations are frequently prescribed, yet few clinical studies have examined this practice. Risperidone, an atypical antipsychotics, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to haloperidol. It has been reported that a relatively low daily dose of haloperidol at which individual patients develop slightly increase in EPS and has neurocognitive benefits as risperidone. The objective of the study is to compare the efficacy and safety of the fixed-dosed risperidone and risperidone combined with haloperidol in the treatment of acute psychotic exacerbations of schizophrenia.In this 6-week, double-blind, fixed-dose study, patients with schizophrenic disorder (DSM-IV diagnosis) are randomly assigned to risperidone (4 mg/d) or risperidone (2 mg/d) plus haloperidol (2 mg/d). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The primary efficacy measure is change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores; secondary outcomes include Clinical Global Impression-Change (CGI-C), the Calgary Depression Scale for Schizophrenics (CDSS), subject-reported outcomes via the Short Form-36 (SF-36), auditory evoked potentials (AEPs), and cognitive and social functioning. Safety assessments include the change from baseline on Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and UKU Side-effects Rating Scale (UKU), and the change from baseline in prolactin levels, body weight, AC glucose level, lipid panel (cholesterol, high density lipid protein [HDL], low density lipid protein [LDL], and triglyceride [TG])

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia

• Clinical Global Impression large than 3

• Written informed consent

Exclusion Criteria:

• Comorbid of substance abuse/dependence

• Present or history of tardive dyskinesis or neuroleptic malignant syndromes

• Severe physical problems

• pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• risperidone
risperidone 4mg/d

Locations

Country	Name	City	State
Taiwan	Kai-Suan Psychiatric Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Kai-Suan Psychiatric Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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 Ps — View Citation

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. — View Citation

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. — View Citation

Woods SW. Chlorpromazine equivalent doses for the newer atypical antipsychotics. J Clin Psychiatry. 2003 Jun;64(6):663-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores		6 weeks after the initiation of antipsychotic use	No