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AzTrials

SchizophreniaPhase 4NCT01615185

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

A Phase 4 study testing full-dose amisulpride in people with Schizophrenia, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
full-dose amisulpride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteTaiwan
Study dates
Jan 2008to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kai-Suan Psychiatric Hospital

    Kaohsiung City, 802

Other trials in Taiwan

About this study

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.

Read the 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]).

Conditions
Schizophrenia
Being tested
full-dose amisulpride
Keywords
schizophrenia, amisulpride, sulpiride, antipsychotic combination
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • full-dose amisulprideDrug

    Also called Solian

    amisulpride 800mg/d

Study groups in NCT01615185
Study groupRoleWhat they receive
sulpiride plus amisulprideExperimentalsulpiride 800mg/d + amisulpride 400mg/d
Receives: Drug: full-dose amisulpride
full-dose amisulprideActive comparatoramisulpride 800mg/d
Receives: Drug: full-dose amisulpride

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

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

    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)

    Measured: 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).

  2. Assessments of safety for extrapyramidal symptoms (EPS)

    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)

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

  3. Assessments of safety for general adverse events

    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".

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

  4. Other safety of clinical trial

    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.

    Measured: 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.

  5. Assessments of quality of life

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01615185
Sponsor's protocol ID
KSPH-2008-13
Other IDs
KSPH-2008-13
Status last verified
Feb 2016
First submitted
3 Jun 2012
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12747876

  • 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.

    PubMed 11229973

  • 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.

    PubMed 15521794

  • 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.

    PubMed 16870959

  • 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.

    PubMed 23778382

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing full-dose amisulpride in people with Schizophrenia, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01615185, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.

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