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Can a natural brain chemical sharpen thinking in schizophrenia?

NCT ID NCT05046353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether D-serine, a natural brain chemical, can improve learning and memory in people with schizophrenia. Participants take D-serine or a placebo for 16 weeks while doing auditory training exercises. The goal is to see if D-serine helps the brain adapt and learn better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D-serine
What this could lead to
If it works, this could point toward a way to improve memory and thinking in people with schizophrenia.
What could go wrong
This is an early-phase trial that is currently suspended, so results are uncertain. D-serine may not provide meaningful cognitive benefits, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18 and 50 2. DSM-V diagnosis of schizophrenia or schizoaffective disorder 3. Willing to provide informed consent 4. Auditory Cognitive impairment demonstrated by: a .MCCB composite domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) b. And at least one of the following: 5. MCCB verbal memory domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) 6. Tone matching score of less than or equal to 77.7% 7. Clinically stable for 2 months (CGI less than or equal to 4) 8. Moderate or lower cognitive disorganization (PANSS P2 less than or equal to 4) 9. Medically stable for study participation 10. Willing to use qualified methods of contraception for the study duration and up to 2 months after its end 11. Fluent English speaker 12. Normal hearing 13. Visual acuity corrected to 20/30 14. An estimated Glomerular Filtration Rate (GFR) greater than or equal to 60 15. Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks 16. Judged clinically not to be at significant suicide or violence risk Exclusion Criteria: 1. Substance abuse (excluding nicotine) within last 60 days 2. ECG abnormality that is clinically significant in the context of study participation in the opinion of the study cardiologist 3. Current clozapine use. Clozapine is excluded for two reasons: to avoid the potential confound of treatment resistant patients and because of clozapine's intrinsic NMDA agonist 4. Participation in study of investigational medication/device within 4 weeks 5. Pregnant women or women of child-bearing potential, who are either not surgically-sterile or for outpatients, using appropriate methods of birth control. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at screening. 6. Presence of positive history of unstable significant medical or neurological illness 7. Positive toxicology screen for any substances of abuse 8. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYSPI

    New York, New York, 10032, United States

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Other studies related to the condition(s) this trial covers.