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DSP-1349M for 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

Summary

A study to determine the maximum tolerated dose of an investigational drug in subjects with 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Hypoaesthesia
17%
Constipation
17%
Dermatitis allergic
17%
Headache
17%
Upper respiratory tract infection
17%
Vision blurred
17%
Abdominal pain lower
17%
Fatigue
17%
Food allergy
17%
Muscle spasms
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

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
239 Previous Clinical Trials
52,957 Total Patients Enrolled
45 Trials studying Schizophrenia
9,280 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
191 Previous Clinical Trials
50,656 Total Patients Enrolled
45 Trials studying Schizophrenia
9,280 Patients Enrolled for Schizophrenia
~6 spots leftby Jul 2025
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