NIPH Clinical Trials Search

Ziprasidone Open Label Study (Phase II)

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Schizophrenia
Date of first enrollment	21/02/2012
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : ME2112 capsule 40mg, ME2112 capsule 60mg INN of investigational material : ziprasidone Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Twice a day, oral administration of 40 mg, 60 mg or 60 mg with meal (80 mg/day ~ 160 mg/day)

Outcome(s)

Primary Outcome	Adverse events and Adverse drug reactions Incidence
Secondary Outcome	PANSS Changes from baseline

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 64age old
Gender	Both
Include criteria	Patient with Schizophrenia as defined with DSM-IV-TR who meet all inclusion criteria and do not meet all exclusion criteria. - Patients with a PANSS total score between 50 and 120, inclusive, at the baseline visit - Patients who have been explained study objectives, methods and other aspects of study, and can give voluntary consent in writing
Exclude criteria	- Patients of treatment resistant schizophrenia - Patients with a primary active mental illness diagnosis other than schizophrenia - Patients with a history of significant cardiovascular disease - Patients with treated but uncontrolled hematological, hepatic, renal, respiratory, gastrointestinal, endocrine, or neurological diseases, or other clinically significant concomitant physical diseases - Patients who had received other investigational drugs within 90 days prior to baseline - Patients considered not to be eligible by the investigator etc.