A Phase 4 interventional study of full-dose amisulpride in Schizophrenia, sponsored by Kaohsiung Kai-Suan Psychiatric Hospital. Terminated at 1 site in Taiwan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by Kaohsiung Kai-Suan Psychiatric Hospital · Phase 4, Interventional, and Treatment
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.
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]).
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 96 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Kaohsiung Kai-Suan Psychiatric Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
sulpiride 800mg/d + amisulpride 400mg/d
Drug: full-dose amisulpride
amisulpride 800mg/d
Drug: full-dose amisulpride
amisulpride 800mg/d
Also known as: Solian
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).
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)
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).
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)
Time frame: 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
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".
Time frame: UKU was administered at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination)
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.
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.
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.
Time frame: Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Amisulpride
Kaohsiung Kai-Suan Psychiatric Hospital