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SOLIAN (AMISULPRIDE): CLINICAL TRIALS
The efficacy of amisulpride in the treatment of schizophrenia has been established on the basis of eleven phase II and III studies conducted in 20 countries and involving 1933 patients (1247 treated with amisulpride) belonging to two distinct populations:
patients with acute exacerbations of schizophrenia
patients with predominant negative schizophrenia
These studies form the basis of the registration documentation for Amisulpride (Solian). Seven of them are considered pivotal for efficacy and their results are summarized below.
Acute exacerbations of schizophrenia
In four well-controlled double-blind studies versus reference medicines in patients with acute schizophrenia according to DSM III-R and DSM-IV criteria, amisulpride was at least as effective as haloperidol, flupenthixol and risperidone. In addition to its global antipsychotic activity, amisulpride significantly alleviated secondary negative symptoms as well as affective symptoms such as depressed mood and retardation.
1. A 4-week double-blind active-controlled trial (n=319) compared four fixed doses of amisulpride (100 mg/d, 400 mg/d, 800 mg / day and 1200 mg/d) and a fixed dose of haloperidol (16 mg/d). A dose response relationship was clearly established in comparison to 100 mg/d, chosen as a potentially subtherapeutic dose in acute schizophrenia. Solian (Amisulpride) tablets and solution at doses of 400 and 800 mg / day statistically significantly improved positive symptoms (BPRS total score, PANSS positive symptoms subscale) compared with amisulpride 100 mg/d. 800 mg / day of amisulpride was also statistically significantly superior to 100 mg / day for response rates based on the CGI.
2. Efficacy results were similar in the three other short-term controlled studies where 800 mg / day of Amisulpride (Solian) tablets and solution was compared with 20 mg / day of haloperidol (n=191), 1000 mg / day of amisulpride with 25 mg / day of flupenthixol (n=132) and 800 mg / day of amisulpride with 8 mg of risperidone (n=228). On BPRS total score and PANSS positive subcale, amisulpride was not found to be different from haloperidol and flupenthixol and showed equivalent efficacy to risperidone. Additionally, amisulpride significantly improved the response rate with CGI versus haloperidol.
Predominant negative schizophrenia
Three pivotal trials were conducted versus placebo in schizophrenic patients with predominant negative symptoms according to DSM III and DSM III-R, showing that low doses of amisulpride are active against negative symptoms.
1. In a six-week dose finding study (n=104), amisulpride 100 mg / day and 300 mg / day were significantly better than placebo on the basis of the SANS total score.
2. In an additional 3-month dose finding study (n=242) testing two fixed dose of amisulpride (50 mg / day and 100 mg/d) versus placebo, both doses of amisulpride were significantly more active in improving the negative symptoms than placebo on the SANS total score. Additionally, there was a significant improvement of the MADRS scores in the two amisulpride groups.
3. A medium-/long-term placebo controlled study with Amisulpride (Solian) 100 mg / day over 6 months with the possibility of extension up to 12 months was conducted to demonstrate the maintenance of efficacy over time. Amisulpride improved negative symptoms (SANS total score) significantly compared with placebo, and the response rate with CGI was significantly higher in the amisulpride group versus placebo. The results were confirmed by the significant improvement of global functioning measured with the GAF. SANS total score remained stable over time up to 12 months, indicating that 100 mg / day not only maintains the improvement of negative symptoms but has also an effect on preventing the recurrence of positive symptoms.
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