Completed

A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia

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What is being tested

Lurasidone

+ Placebo
Drug
Who is being recruted

Mental Disorders

+ Schizophrenia
+ Schizophrenia Spectrum and Other Psychotic Disorders
From 18 to 64 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Official TitleA Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia 
NCT00088634
Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
180 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mental Disorders
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Criteria

Inclusion Criteria: * Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV * The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment * If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception Exclusion Criteria: * The patient has used an investigational drug within the past 30 days * The patient has participated in a previous study of this compound

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
80 mg AM dosing once daily

80 mg AM dosing once daily
Group II
Placebo

Matching Placebo to 40mg lurasidone tablets
Study Objectives
Primary Objectives

The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.
Secondary Objectives

The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.

The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 22 locations
Suspended
Birmingham Psychiatry PharmaceuticalBirmingham, United StatesSee the location
Suspended
Summit Research GroupLittle Rock, United States
Suspended
Comprehensive NeuroScienceCerritos, United States
Suspended
Collaborative Neuro Science Network, Inc.Garden Grove, United States
Completed22 Study Centers
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