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

NCT01615185 | Terminated Phase 4 DMC

• 1 other identifier: KSPH-2008-13
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenia; amisulpride; sulpiride; antipsychotic combination

Outcome Measures

Primary Outcomes (1)

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

  The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

Secondary Outcomes (5)

• changes from baseline in the scores on several psychopathology scales for efficacy

  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).

• Assessments of safety for extrapyramidal symptoms (EPS)

  AIMS, BAS, and SAS were administered at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination)

• Assessments of safety for general adverse events

  UKU was administered at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination)

• Other safety of clinical trial

  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.

• Assessments of quality of life

  Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6

Study Arms (2)

sulpiride plus amisulpride

EXPERIMENTAL

sulpiride 800mg/d + amisulpride 400mg/d

Drug: full-dose amisulpride

full-dose amisulpride

ACTIVE COMPARATOR

amisulpride 800mg/d

Drug: full-dose amisulpride

Interventions

full-dose amisulpride DRUG

amisulpride 800mg/d

Also known as: Solian

full-dose amisulpride; sulpiride plus amisulpride

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Kai-Suan Psychiatric Hospital: lead

Study Sites (1)

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

Location

Related Publications (5)

• Leucht S, Wahlbeck K, Hamann J, Kissling W. New generation antipsychotics versus low-potency conventional antipsychotics: a systematic review and meta-analysis. Lancet. 2003 May 10;361(9369):1581-9. doi: 10.1016/S0140-6736(03)13306-5.

  PMID: 12747876 RESULT

• Kapur S, Seeman P. Does fast dissociation from the dopamine d(2) receptor explain the action of atypical antipsychotics?: A new hypothesis. Am J Psychiatry. 2001 Mar;158(3):360-9. doi: 10.1176/appi.ajp.158.3.360.

  PMID: 11229973 RESULT

• McKeage K, Plosker GL. Amisulpride: a review of its use in the management of schizophrenia. CNS Drugs. 2004;18(13):933-56. doi: 10.2165/00023210-200418130-00007.

  PMID: 15521794 RESULT

• Chakos MH, Glick ID, Miller AL, Hamner MB, Miller DD, Patel JK, Tapp A, Keefe RS, Rosenheck RA. Baseline use of concomitant psychotropic medications to treat schizophrenia in the CATIE trial. Psychiatr Serv. 2006 Aug;57(8):1094-101. doi: 10.1176/ps.2006.57.8.1094.

  PMID: 16870959 RESULT

• Lin CH, Wang FC, Lin SC, Huang YH, Chen CC, Lane HY. Antipsychotic combination using low-dose antipsychotics is as efficacious and safe as, but cheaper, than optimal-dose monotherapy in the treatment of schizophrenia: a randomized, double-blind study. Int Clin Psychopharmacol. 2013 Sep;28(5):267-74. doi: 10.1097/YIC.0b013e3283633a83.

  PMID: 23778382 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ching-Hua Lin, MD, PhD

  Kai-Suan Psychiatric Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Psychiatry

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: June 8, 2012
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

TW (1)