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Not yet recruitingNCT07850102Updated Sep 30, 2026

Brain Imaging of DSP-2342

A Phase 2 interventional study of DSP-2342 in SCHIZOPHRENIA 1 (Disorder), sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Johns Hopkins University · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

Read the detailed description

Many symptomatic domains in schizophrenia, with the exception of positive symptoms, are inadequately addressed by currently available antipsychotics, all of which rely on dopamine D2 receptor blockade. This blockade also elicits several major side effects. Conversely, some atypical antipsychotics possess additional receptor-binding capacities (e.g., targeting 5-HT2A and 5-HT7 receptors) and exhibit some efficacy against non-positive symptoms, such as cognitive dysfunction. Focusing on these clinico-pharmacological features, DSP has developed a novel compound that selectively binds to 5-HT2A and 5-HT7 receptors without interacting with the D2 receptor. This compound has been tested at the clinical level at a single dose, which was formally approved. Thus, the investigators plan to evaluate the neural effects of a single oral dose of DSP-2342 on brain chemistry and brain activity in adults with schizophrenia. Guided by preclinical data for DSP-2342, the investigators will measure brain chemistry using magnetic resonance spectroscopy (MRS) and brain activity via task-based functional MRI (fMRI), comparing these measures before and after a single dose of DSP-2342. Based on these preclinical findings, the investigators hypothesize that DSP-2342 will produce measurable changes in brain chemistry, such as altering glutamate levels in the prefrontal cortex.

02

Conditions studied

  • SCHIZOPHRENIA 1 (Disorder)

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Keywords

  • schizophrenia
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

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

    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

  • DrugDSP-2342

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

05

What researchers measure

Primary outcomes

  1. Glutamate levels (a.u.)

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

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

06

Study locations

1 site
  • johns Hopkins University
    Baltimore, Maryland 21287, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07850102
Lead sponsor
Johns Hopkins University
Collaborators
Sumitomo Pharmaceuticals America
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Akira Sawa, MD
Contact
asawa1@jhmi.edu
443-846-1409
Kristin Bigos, PhD
Contact
kbigos1@jhu.edu
412-480-3933
Akira Sawa, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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