SCHIZOPHRENIA 1 (Disorder)Phase 2NCT07850102
Brain Imaging of DSP-2342
A Phase 2 study testing DSP-2342 in people with SCHIZOPHRENIA 1 (Disorder), run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators aim to determine the effects of a novel drug on brain function and brain chemistry in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder)
- What is being tested?
- DSP-2342
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- right-handed, participants with schizophrenia between the ages of 18-50 years.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
johns Hopkins University
Baltimore, Maryland, 21287
akira sawa, professor,, MD, 443-846-1409, asawa1@jhmi.edu
About this study
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.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Being tested
- DSP-2342
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-2342Drug
a single oral dose of DSP-2342 on brain chemistry and brain activity in adults with schizophrenia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DSP-2342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate levels (a.u.)
brain chemistry (e.g. glutamate levels in the prefrontal cortex) measured by Magnetic Resonance Spectroscopy (MRS)
Measured: one MRS scan on the same day of drug administration (acute effect)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals America
- Responsible party
- Sponsor
- Investigators
- Akira Sawa, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850102
- Sponsor's protocol ID
- IRB00515260
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of DSP-2342
- ClinicalTrials.gov ID
- NCT07850102
- Acronym / sponsor ID
- IRB00515260
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Keywords
- schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals America
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to determine the effects of a novel drug on brain function and brain chemistry in patients with schizophrenia.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the neural effects of a single oral dose of DSP-2342 | Experimental | Drug: DSP-2342The 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- right-handed, participants with schizophrenia between the ages of 18-50 years.
Key exclusion criteria (13 listed)
- Current substance misuse
- Pregnancy or breast feeding
- Subjects with electrocardiographic abnormalities (particularly QTc prolongation)
- Subjects with renal impairment
- Subjects with hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP-2342a single oral dose of DSP-2342 on brain chemistry and brain activity in adults with schizophrenia. | Drug | Evaluation of the neural effects of a single oral dose of DSP-2342 |
Primary outcome
Glutamate levels (a.u.)
Time frame: one MRS scan on the same day of drug administration (acute effect)
brain chemistry (e.g. glutamate levels in the prefrontal cortex) measured by Magnetic Resonance Spectroscopy (MRS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akira Sawa, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DSP-2342 in people with SCHIZOPHRENIA 1 (Disorder), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akira Sawa, MD (443-846-1409, asawa1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutamate levels (a.u.) (time frame: one MRS scan on the same day of drug administration (acute effect)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.