Ziprasidone Open Label Study (Phase II)

JRCT ID: jRCT2080221713

Registered date:21/02/2012

Basic Information

• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 21/02/2012
• Target sample size: 20
• 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.

Related Information

• Primary Sponsor: Meiji Seika Pharma Co., Ltd.
• Source(s) of Monetary Support: Meiji Seika Pharma Co., Ltd.
• Secondary ID(s): JapicCTI-121755