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

This study has been terminated.
(terminated)
Sponsor:
Information provided by:
Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier:
NCT00998608
First received: October 8, 2009
Last updated: October 18, 2009
Last verified: October 2009

October 8, 2009
October 18, 2009
August 2007
July 2009   (final data collection date for primary outcome measure)
change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores [ Time Frame: 6 weeks after the initiation of antipsychotic use ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998608 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparison of the Efficacy and Safety of Risperidone Versus Risperidone Plus Low Dose of Haloperidol in the Treatment of Schizophrenia
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

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.

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])

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
Drug: risperidone
risperidone 4mg/d
Experimental: HR
risperidone 2mg/d + haloperidol 2mg/d
Intervention: Drug: risperidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
October 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00998608
KSPH-2007-17
Yes
Ching-Hua Lin, M.D., Kaohsiung Kai-Suan Psychiatric Hospital
Kaohsiung Kai-Suan Psychiatric Hospital
Not Provided
Study Director: Li-Shiu Chou, M.D. Kai-Suan Psychiatric Hospital
Kaohsiung Kai-Suan Psychiatric Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP