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A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

Phase 1
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 61
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing an injectable form of lurasidone in people with schizophrenia to find the safest and most effective dose. The study will see how the drug behaves in the body and determine the highest dose that can be tolerated without severe side effects. Lurasidone is a second-generation antipsychotic approved for the treatment of schizophrenia, known for its favorable metabolic profile and once-daily dosing regimen.

Eligible Conditions
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 61
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 61 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration

Side effects data

From 2019 Phase 1 trial • 40 Patients • NCT03627195
17%
Food allergy
17%
Constipation
17%
Dermatitis allergic
17%
Vision blurred
17%
Abdominal pain lower
17%
Fatigue
17%
Upper respiratory tract infection
17%
Muscle spasms
17%
Headache
17%
Hypoaesthesia
17%
Anxiety
17%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lurasidone 30 mg
Lurasidone 75 mg
Lurasidone 150 mg
Lurasidone 300 mg
Lurasidone 450 mg
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DSP-1349MExperimental Treatment1 Intervention
Lurasidone injection suspension (30 mg, 75 mg, 150 mg, 300 mg, and 450 mg)
Group II: PlacboPlacebo Group1 Intervention
placebo injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurasidone
FDA approved

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,406 Total Patients Enrolled
45 Trials studying Schizophrenia
9,291 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
189 Previous Clinical Trials
48,894 Total Patients Enrolled
45 Trials studying Schizophrenia
9,291 Patients Enrolled for Schizophrenia
~5 spots leftby Dec 2025
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