Clinical trial NCT03393026: A Study of Lurasidone HCl in Subjects With Schizophrenia
Official title: A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Standard Chem. & Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lurasidone 40-160 mg/day
Primary purpose: TREATMENT

Brief summary: The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks.


Eligibility criteria: Inclusion Criteria:

1. Males or female aged at 20-75 years old
2. Subjects who are diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
3. CGI-S≦4 (at both screening and baseline)
4. Subject is judged by the investigator to have been clinically stable for at least 4 weeks prior to baseline and in need for a switch from their current antipsychotic treatment due to insufficient clinical response or poor tolerability (side effects, metabolic complications, etc.).
5. If the subject recruits from OPD, the subject should be intolerant to the AE or is insufficient in current antipsychotics treatment by investigator's judgment.
6. Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
7. Subject is able and agrees to remain off (or stable dosage) prior antipsychotic medication during the study period as defined by this protocol.
8. In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
9. Subject is willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject has clinically substantial risk of suicide or violent behavior as judged by the investigator.
2. Subject with the past history of neuroleptic malignant syndrome, water intoxication, paralytic ileus or dementia related psychosis
3. Subjects is active pregnancy (must have a negative pregnancy test at screening) or nursing (must not be lactating).
4. Subject has received treatment with MAO inhibitors within 14 days prior to the screening (Visit 1).
5. Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 1 month prior to signing the informed consent.
6. Subject is unstable or critical untreated medical illness by the judgment of investigators.
7. Subject who is otherwise considered ineligible for the study by investigator. For example, subjects experienced serious medical condition including known clinically relevant laboratory abnormalities, and hypersensitivity to Lurasidone.
8. Subjects who were considered resistance to treatment for psychotic symptoms by the investigator.
9. Total daily dose of pre-switch antipsychotic was exceeded the equivalent of haloperidol 12 mg/day.
10. Subjects have received long depot neuroleptics within 4 weeks prior to enrollment. Or, subject was treated with clozapine for refractory psychosis within 1 month of enrollment.
11. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study. Subject requires treatment with a drug that consistently prolongs the QTc interval.

Primary outcomes:
measure: time to treatment failure.
timeFrame: 6 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale(PANSS) total scores
timeFrame: 6 weeks
measure: Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: 6 weeks
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital, Songde Branch
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: