ME2112 Phase III (ME2112-2)

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2015
INTERVENTION: Intervention name : ME2112 INN of the intervention : Ziprasidone Dosage And administration of the intervention : Orally administer a dose of 2 capsules twice daily (40 mg BID, 60 mg BID, 80 mg BID) during or immediately after morning and evening meals. Control intervention name : Placebo Dosage And administration of the control intervention : Orally administer a dose of 2 capsules twice daily during or immediately after morning and evening meals. CONDITION: Schizophrenia PRIMARY OUTCOME: PANSS total score. SECONDARY OUTCOME: PANSS subscore.; Clinical Global Impression‐Severity of illness (CGI‐S).; Clinical Global Impression‐Global Improvement (CGI‐I).; Adverse events. INCLUSION CRITERIA: 1)Patients with a diagnosis of schizophrenia as defined by DSM‐5. 2)Written consent can be obtained from the patient. 3)Patient's condition is confirmed to be the acute exacerbation period of schizophrenia by the investigator or sub‐investigator. etc.
Epistemonikos ID: 8d7e52a5b0f82142ceeb20b03887a62254f31f33
First added on: Aug 23, 2024