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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.
Information provided by:
Kaohsiung Kai-Suan Psychiatric Hospital Identifier:
First received: October 8, 2009
Last updated: October 18, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Schizophrenia Drug: risperidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Kaohsiung Kai-Suan Psychiatric Hospital:

Primary Outcome Measures:
  • change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores [ Time Frame: 6 weeks after the initiation of antipsychotic use ]

Enrollment: 88
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HR
risperidone 2mg/d + haloperidol 2mg/d
Drug: risperidone
risperidone 4mg/d

Detailed 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])

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00998608

Kai-Suan Psychiatric Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Kai-Suan Psychiatric Hospital
Study Director: Li-Shiu Chou, M.D. Kai-Suan Psychiatric Hospital
  More Information

Responsible Party: Ching-Hua Lin, M.D., Kaohsiung Kai-Suan Psychiatric Hospital Identifier: NCT00998608     History of Changes
Other Study ID Numbers: KSPH-2007-17
Study First Received: October 8, 2009
Last Updated: October 18, 2009

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents processed this record on August 18, 2017