A Randomized, Double-blind, Comparison of the Efficacy and Safety of Amisulpride Versus Low-dose Amisulpride Plus Low-dose Sulpiride in the Treatment of Schizophrenia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier:
NCT01615185
First received: June 3, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

Background: Surveys have shown that antipsychotic drug combinations are frequently prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.

Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost.


Condition Intervention Phase
Schizophrenia
Drug: full-dose amisulpride
Phase 4

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

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: The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes from baseline in the scores on several psychopathology scales for efficacy [ Time Frame: The CGI-S, PANSS, CDSS, and GAF were rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination). ] [ Designated as safety issue: No ]
    psychopathology scales for efficacy include: Clinical Global Impression-Severity (CGI-S), PANSS positive scale, PANSS negative scale, PANSS general psychopathology scale, Calgary Depression Scale for Schizophrenia (CDSS), and Global Assessment of Functioning (GAF)

  • Assessments of safety for extrapyramidal symptoms (EPS) [ Time Frame: AIMS, BAS, and SAS were administered at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination) ] [ Designated as safety issue: Yes ]
    The severity of EPS was assessed by the following neurological scales: the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and the Simpson-Angus Rating Scale (SAS)

  • Assessments of safety for general adverse events [ Time Frame: UKU was administered at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination) ] [ Designated as safety issue: Yes ]
    General adverse events were evaluated by a standardized the UKU Side Effect Rating Scale. A score of 1, 2 or 3 on any UKU item that first occurred or worsened during treatment indicated adverse events "cases".

  • Other safety of clinical trial [ Time Frame: Body weight, BMI, pulse rate, and blood pressure were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination). ECG and laboratory tests were assessed at baseline and week 6. ] [ Designated as safety issue: Yes ]
    Body weights, body mass index (BMI), pulse rate, blood pressure (systolic and diastolic), 12-lead electrocardiogram (ECG) for QTc intervals (Bazett's correction of QT interval), and laboratory tests were performed to determine safety. Laboratory tests included fasting glucose, liver function (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), renal function (blood urea nitrogen [BUN], creatinine), lipid profiles (triglycerides, cholesterol, high density lipoprotein [HDL], and low density lipoprotein [LDL]), and prolactin level.

  • Assessments of quality of life [ Time Frame: Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6 ] [ Designated as safety issue: No ]
    The SF-36, with two primary-factor analytic components: the physical component summary and the mental component summary, was used to measure quality of life.


Enrollment: 96
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sulpiride plus amisulpride
sulpiride 800mg/d + amisulpride 400mg/d
Drug: full-dose amisulpride
amisulpride 800mg/d
Other Name: Solian
Active Comparator: full-dose amisulpride
amisulpride 800mg/d
Drug: full-dose amisulpride
amisulpride 800mg/d
Other Name: Solian

Detailed Description:

Background: 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. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to sulpiride. It has been reported that mean doses of low-potency typical antipsychotics less than 600 mg/day of chlorpromazine equivalent dose has no higher risk of EPS than atypical antipsychotics. The objective of the study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.

Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia (DSM-IV diagnosis) are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The efficacy assessment was the change from baseline in the score on the Clinical Global Impression-Severity (CGI-S), Positive and Negative Syndrome Scale (PANSS) and subscales (positive scale, negative scale, general psychopathology scale), Calgary Depression Scale for Schizophrenia (CDSS), and Global Assessment of Functioning (GAF). 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, vital sign, blood pressure, AC glucose level, and lipid profiles(cholesterol, high density lipid protein [HDL], low density lipid protein [LDL], and triglyceride [TG]).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • schizophrenia
  • CGI >=4
  • washout of antipsychotics at least 3-5 days
  • written informed consents

Exclusion Criteria:

  • History of serious adverse events to sulpiride or amisulpride
  • History of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics
  • treatment-resistant schizophrenia
  • long-acting antipsychotics in the past 3 months
  • comorbid with substance abuse/dependence
  • female subjects with pregnancy
  • severe physical illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615185

Locations
Taiwan
Kai-Suan Psychiatric Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Kai-Suan Psychiatric Hospital
Investigators
Principal Investigator: Ching-Hua Lin, MD, PhD Kai-Suan Psychiatric Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ching-Hua Lin, MD, PhD, Chief of Adult Psychiatry, Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT01615185     History of Changes
Other Study ID Numbers: KSPH-2008-13, KSPH-2008-13
Study First Received: June 3, 2012
Last Updated: June 6, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Kai-Suan Psychiatric Hospital:
schizophrenia
amisulpride
sulpiride
antipsychotic combination

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sulpiride
Sultopride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on September 14, 2014