NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Schizophrenia
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SM-13496 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Efficacy: Changes in BPRS and PANSS total scores from baseline etc Safety: Changes in DIEPSS score from baseline etc
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 64age old
Gender	Both
Include criteria	<Inclusion criteria> -Patients who meet the ICD-10 diagnostic criteria for schizophrenia -Fresh schizophrenic patients suffering from an initial or recurrent episode or schizophrenic patients receiving antipsychotic drugs, who meet the following inclusion criteria at the time of enrollment a) Patients with hallucinations and delusions in the foreground b) Patients with delusions in the foreground c) Patients with loss of spontaneity and blunted affect in the foreground: Type 1 (fresh, hebephrenic) d) Patients with loss of spontaneity and blunted affect in the foreground: Type 2 (chronically illed, fixed symptoms) e) Patients presenting with neurosis-like symptoms in the foreground f) Patients presenting with depressive symptoms in the foreground -Patients aged 18 to less than 65 at the time of informed consent acquisition etc. <Exclusion criteria> -Patients with a history of malignant syndrome, water intoxication, paralytic ileus or with strong suicidal ideation -Patients with Parkinson's disease -Patients with HbA1C level of 8.0% or greater, or whose glycoalbumin level is 23.0% or greater -Patients who have received electroconvulsive therapy within 6 months (180 days) prior to the first dose of the investigational product etc.
Exclude criteria