schizophrenia
Conditions
Interventions
Group 1:IM ziprasidone
Group 2:Ziprasidone Hydrochloride Capsules
Sponsors
Beijing Hui Long Guan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects meeting the DSM-IV/5ICD-10CCMD-2/3 criteria for schizophrenia; 2. Male or female Chinese subjects aged 18-65 years; 3. Subjects who are hospitalized (in-hospital patients) at screening phase, and can remain in hospital during study period; 4. Subjects who are in acute exacerbation of schizophrenia with a score from 70 to 120 on the PANSS scale and are appropriate to receive intramuscular medication according to the investigators judgment; 5. Subjects with a minimum score of 14 on the PANSS -excited component(PANSS-EC) score with at least 1 item no less than 4.(P4. excited, P7. Hostility, G4. Physical tension, G8. Uncooperative, G14. Impulse control disorder); 6. Evidence of a subject(or a legal representative) signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and are willing to participate in it.
Exclusion criteria
Exclusion criteria: 1. Agitation due to delirium, seizures, affective psychosis, poisoning, or substance abuse withdrawal reactions; 2. Relevent history or current presence of any cardiovascular, respiratory, neurological, renal, hepatic, endocrine, immunologic or other systemic disease; 3. Confirmed clinically significant abnormal laboratory values; 4. Clinically significant ECG abnormality; 5. Subjects with a history of QTc prolongation or a pre-drug QTc of 450 msec or greater; 6. Subjects with serum K+ or Mg2+ beyond the normal range; 7. A history of malignant syndrome or tardive dyskinesia history; 8. Pregnant or lactating women; 9. Concomitant use of drugs which may induce QTc prolongation during the study such as Sotalol, quinidine, amiodarone, erythromycin, clozapine and clomipramine; 10. Treatment resistance to conventional drugs. (Treatment resistance is defined as failure to experience a therapeutic response during acute exacerbation of schizophrenia following adequate treatment with marketed antipsychotic agents on two or more occasions based on the judgement of investigator during the 2 years prior to study entry); 11. Known allergy to ziprasidone; 12. Using of long-acting antipsychotics in the previous 1 month prior to screening; 13. Participation in other studies within the last 30 days before the current study begins and /or during study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS score;BARS score;CGI-S score; | — |
Countries
China
Contacts
Public ContactYang Fude
Outcome results
None listed