Brain Imaging of DSP-2342

NCT07850102 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00515260
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to determine the effects of a novel drug on brain function and brain chemistry in patients with schizophrenia.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• Glutamate levels (a.u.)

  brain chemistry (e.g. glutamate levels in the prefrontal cortex) measured by Magnetic Resonance Spectroscopy (MRS)

  one MRS scan on the same day of drug administration (acute effect)

Study Arms (1)

Evaluation of the neural effects of a single oral dose of DSP-2342

EXPERIMENTAL

The primary goal of this study is to evaluate the neural effects of a single oral dose of DSP-2342 on brain chemistry and brain activity in adults with schizophrenia. The investigators will measure brain chemistry using magnetic resonance spectroscopy and brain activity using task-based functional MRI. The investigators will compare these measures before and after a single dose of DSP-2342.

Drug: DSP-2342

Interventions

DSP-2342 DRUG

a single oral dose of DSP-2342 on brain chemistry and brain activity in adults with schizophrenia.

Evaluation of the neural effects of a single oral dose of DSP-2342

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• right-handed, participants with schizophrenia between the ages of 18-50 years.

You may not qualify if:

• Current substance misuse
• Pregnancy or breast feeding
• Subjects with electrocardiographic abnormalities (particularly QTc prolongation)
• Subjects with renal impairment
• Subjects with hepatic impairment
• Past or current neurological disorder (including stroke, brain tumor, epilepsy, Alzheimer's, Parkinson's or Huntington's disease)
• Non-schizophrenia cause of cognitive impairment
• Uncontrolled medical disorder that may interfere with cognition or compromise safety
• Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
• Having a contraindication to MRI, including a pacemaker, defibrillator or other medical implant, other metal objects, or claustrophobia, or for having braces or other metal in the head region (likely to create an artifact on the MRI scans).
• Significant suicidal ideation
• Recent history of electroconvulsive therapy
• Medication changes in the past six weeks

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sumitomo Pharmaceuticals America: collaborator

Study Sites (1)

johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Akira Sawa, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akira Sawa, MD

CONTACT

443-846-1409; asawa1@jhmi.edu

Kristin Bigos, PhD

CONTACT

412-480-3933; kbigos1@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)