A Study of Lurasidone HCl in Subjects With Schizophrenia

Last updated: February 2, 2020
Sponsor: Standard Chem. & Pharm. Co., Ltd.
Overall Status: Completed

Phase

4

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT03393026
SCPF20L01TW
  • Ages 20-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males or female aged at 20-75 years old

  2. Subjects who are diagnosed with schizophrenia based on Diagnostic and StatisticalManual 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 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.).

  5. If the subject recruits from OPD, the subject should be intolerant to the AE or isinsufficient in current antipsychotics treatment by investigator's judgment.

  6. Childbearing potential women who consented to the consistent use of the acceptablecontraception (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 antipsychoticmedication during the study period as defined by this protocol.

  8. 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.

  9. Subject is willing and able to comply with the protocol.

Exclusion

Exclusion Criteria:

  1. Subject has clinically substantial risk of suicide or violent behavior as judged bythe 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) ornursing (must not be lactating).

  4. Subject has received treatment with MAO inhibitors within 14 days prior to thescreening (Visit 1).

  5. 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.

  6. Subject is unstable or critical untreated medical illness by the judgment ofinvestigators.

  7. 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.

  8. Subjects who were considered resistance to treatment for psychotic symptoms by theinvestigator.

  9. Total daily dose of pre-switch antipsychotic was exceeded the equivalent ofhaloperidol 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 ofenrollment.

  11. 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

Total Participants: 54
Study Start date:
January 03, 2018
Estimated Completion Date:
September 17, 2019

Connect with a study center

  • Taipei City Hospital, Songde Branch

    Taipei,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei,
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.