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NMDAR Agonist

D-serine for Schizophrenia

Phase 1 & 2
Waitlist Available
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test if D-serine can help people with schizophrenia by improving their cognitive abilities.

Who is the study for?
Adults aged 18-50 with schizophrenia or schizoaffective disorder, stable on antipsychotic medication (excluding clozapine), and showing specific cognitive impairments can join. They must be medically stable, not at risk of suicide or violence, have normal hearing and vision (corrected to 20/30), and agree to use contraception. Substance abuse within the last 60 days or significant medical conditions are disqualifiers.Check my eligibility
What is being tested?
The trial is testing D-serine's effect on auditory plasticity in schizophrenia over a period of 16 weeks against a placebo. Participants will undergo tests for cognitive functions like memory and attention to see if D-serine improves learning abilities linked to brain receptors involved in these processes.See study design
What are the potential side effects?
Potential side effects aren't specified here but may include reactions related to NMDA receptor activation such as headaches, dizziness, or gastrointestinal issues since D-serine targets glutamate receptors in the brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Auditory Cognition

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: D-serineExperimental Treatment1 Intervention
Subjects will receive 16 sessions of auditory remediation paired with either D-serine or Placebo in a 1:1 D-serine 120 mg/kg:placebo ratio.
Group II: placeboPlacebo Group1 Intervention
Subjects will receive 16 sessions of auditory remediation paired with either D-serine or Placebo in a 1:1 D-serine 120 mg/kg:placebo ratio.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-serine
2014
Completed Phase 4
~350

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,847 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,067 Total Patients Enrolled
Nathan Kline Institute for Psychiatric ResearchOTHER
37 Previous Clinical Trials
2,768 Total Patients Enrolled

Media Library

D-serine (NMDAR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05046353 — Phase 1 & 2
Schizoaffective Disorder Research Study Groups: D-serine, placebo
Schizoaffective Disorder Clinical Trial 2023: D-serine Highlights & Side Effects. Trial Name: NCT05046353 — Phase 1 & 2
D-serine (NMDAR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046353 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process for this investigation still ongoing?

"This trial is no longer recruiting new participants, as evidenced by its initial posting date of December 15th 2022 and most recent update on October 26th 2022. However, if you're seeking alternative studies to join, there are currently 491 trials focused on schizophrenia that require volunteers and 1 clinical trial centered around D-serine."

Answered by AI

Does this research program offer participation to seniors aged 75 or higher?

"According to the requirements of this medical investigation, only individuals aged 18-50 are permitted entry into the study."

Answered by AI

To what demographic is this clinical trial open?

"In order to qualify for this trial, individuals must have schizophrenia and be between 18-50 years old. The research seeks a total of 60 participants."

Answered by AI

How many participants are being recruited for this trial?

"Unfortunately, this medical trial is no longer accepting new participants. Originally posted on December 15th 2022 and last edited October 26th 2022, the study has since been closed to recruitment. Presently, there are 491 trials recruiting patients with schizophrenia and a single trial for D-serine looking for volunteers."

Answered by AI

Are there any analogous studies of D-serine's efficacy?

"Presently, there is only one active clinical trial exploring the efficacy of D-serine and it has yet to reach Phase 3. This investigation is being conducted in New york City with no other locations running similar experiments."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
D-serine AudRem: R33 Phase
Joshua Kantrowitz 2022. "D-serine AudRem: R33 Phase". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046353.
~24 spots leftby Apr 2025
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