A Study of Lurasidone HCl in Subjects With Schizophrenia

NCT03393026 | Completed Phase 4

• 1 other identifier: SCPF20L01TW
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• time to treatment failure.

  Treatment failure is defined as any occurrence of: Insufficient clinical response Exacerbation of underlying disease Discontinuation due to adverse event

  6 weeks

Secondary Outcomes (3)

• Positive and Negative Syndrome Scale(PANSS) total scores

  6 weeks

• Clinical Global Impression-Improvement (CGI-I) Scale

  6 weeks

• Clinical Global Impression-Severity (CGI-S)

  6 weeks

Study Arms (1)

Lurasidone 40-160 mg

EXPERIMENTAL

Lurasidone 40-160 mg

Drug: Lurasidone

Interventions

Lurasidone DRUG

Lurasidone 40-160 mg/day for 6 weeks

Lurasidone 40-160 mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or female aged at 20-75 years old
• Subjects who are diagnosed with schizophrenia based on Diagnostic and Statistical Manual 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 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.).
• 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.
• 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)
• Subject is able and agrees to remain off (or stable dosage) prior antipsychotic medication during the study period as defined by this protocol.
• 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.
• Subject is willing and able to comply with the protocol.

You may not qualify if:

• Subject has clinically substantial risk of suicide or violent behavior as judged by the 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) or nursing (must not be lactating).
• Subject has received treatment with MAO inhibitors within 14 days prior to the screening (Visit 1).
• 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.
• Subject is unstable or critical untreated medical illness by the judgment of investigators.
• 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.
• Subjects who were considered resistance to treatment for psychotic symptoms by the investigator.
• Total daily dose of pre-switch antipsychotic was exceeded the equivalent of haloperidol 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 of enrollment.
• 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.

Sponsors & Collaborators

• Standard Chem. & Pharm. Co., Ltd.: lead

Study Sites (2)

Taipei City Hospital, Songde Branch

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Lurasidone 40-160 mg/day

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 8, 2018
• Study Start: January 3, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TW (2)