Phase
Condition
Psychosis
Tourette's Syndrome
Schizotypal Personality Disorder (Spd)
Treatment
N/AClinical Study ID
Ages 20-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or female aged at 20-75 years old
Subjects who are diagnosed with schizophrenia based on Diagnostic and StatisticalManual of Mental Disorders (DSM-V) criteria
CGI-S≦4 (at both screening and baseline)
Subject is judged by the investigator to have been clinically stable for at least 4weeks prior to baseline and in need for a switch from their current antipsychotictreatment due to insufficient clinical response or poor tolerability (side effects,metabolic complications, etc.).
If the subject recruits from OPD, the subject should be intolerant to the AE or isinsufficient in current antipsychotics treatment by investigator's judgment.
Childbearing potential women who consented to the consistent use of the acceptablecontraception (oral contraceptive, contraceptive injection, intrauterine device,double barrier method and contraceptive patch)
Subject is able and agrees to remain off (or stable dosage) prior antipsychoticmedication during the study period as defined by this protocol.
In the Investigator's opinion, the ability to understand the nature of the study andany hazards of participation, and to communicate satisfactorily with the investigatorand to participate in, and to comply with, the requirements of the entire protocol.
Subject is willing and able to comply with the protocol.
Exclusion
Exclusion Criteria:
Subject has clinically substantial risk of suicide or violent behavior as judged bythe investigator.
Subject with the past history of neuroleptic malignant syndrome, water intoxication,paralytic ileus or dementia related psychosis
Subjects is active pregnancy (must have a negative pregnancy test at screening) ornursing (must not be lactating).
Subject has received treatment with MAO inhibitors within 14 days prior to thescreening (Visit 1).
Subject is currently participating, or has participated in, a study with aninvestigational or marketed compound or device within 1 month prior to signing theinformed consent.
Subject is unstable or critical untreated medical illness by the judgment ofinvestigators.
Subject who is otherwise considered ineligible for the study by investigator. Forexample, subjects experienced serious medical condition including known clinicallyrelevant laboratory abnormalities, and hypersensitivity to Lurasidone.
Subjects who were considered resistance to treatment for psychotic symptoms by theinvestigator.
Total daily dose of pre-switch antipsychotic was exceeded the equivalent ofhaloperidol 12 mg/day.
Subjects have received long depot neuroleptics within 4 weeks prior to enrollment. Or,subject was treated with clozapine for refractory psychosis within 1 month ofenrollment.
Subject requires treatment with any potent CYP3A4 inhibitors or inducers during thestudy. Subject requires treatment with a drug that consistently prolongs the QTcinterval.
Study Design
Connect with a study center
Taipei City Hospital, Songde Branch
Taipei,
TaiwanSite Not Available
Tri-Service General Hospital
Taipei,
TaiwanSite Not Available
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