The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
1. The title of this study is a multi-center,non randomized,open-labeled,intervention
study:the efficacy and safety of intramuscular ziprasidone for three days in patients
with acute psychotic agitation.
2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in
patients with acute psychotic agitation in daily clinical practice.
3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in
patients with acute psychotic agitation in daily clinical practice.2.To compare the
efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the
different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular
ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the
measured based administration according to severity of symptoms.5.To compare the
efficacy and tolerance of ziprasidone im between the monotherapy and combination with
other antipsychotic drug in clinical practice.
4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on
schizophrenia. But in the foreign country, ziprasidone im also is approved to treat
psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical
practice of China, ziprasidone im is also used to treat other patients, although the
evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation
is effective and safe.
5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and
the hypothesis：The researches of ziprasidone mesylate injection in our country are more
concentrated in schizophrenia at present, while in foreign countries ziprasidone is
approved for psychotic agitation, including mania etc. It's also used for substance
abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone
mesylate injection is effective in the treatment of acute agitation, and it's well
tolerated.