Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer

NCT05052853 | Recruiting Phase 2 DMC

• 1 other identifier: CMUH110-REC3-114
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.

Conditions

Prodromal Schizophrenia

Keywords

Schizophrenia; Prodrome; NMDA

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Scale of Prodromal Symptoms [SOPS] total score

  Assessment of overall prodromal symptoms. Minimum value: 0, maximum value: 114, the higher scores mean a worse outcome. As shown in "Detailed Description", "mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). That is, GEE is used for analyzing the changes from baseline in repeated-measure assessments by a single analysis (but not multiple analyses).

  week 0, 2, 4, 6, 9, 12

Secondary Outcomes (10)

• Change from baseline in SOPS Positive Symptom Scale score

  week 0, 2, 4, 6, 9, 12

• Change from baseline in SOPS Negative Symptom Scale score

  week 0, 2, 4, 6, 9, 12

• Change from baseline in SOPS Disorganization Symptom Scale score

  week 0, 2, 4, 6, 9, 12

• Change from baseline in SOPS General Symptom Scale score

  week 0, 2, 4, 6, 9, 12

• Change from baseline in Scales for the Assessment of Negative Symptoms (SANS) total score

  week 0, 2, 4, 6, 9, 12

Study Arms (2)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAE DRUG

Use of an NMDA enhancer for the treatment of prodromal schizophrenia .

NMDAE

Placebo Cap DRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration).
• Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms \[SOPS\] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period.
• Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period.
• Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject \< 20 years old, a parent also has to provide written informed consent.

You may not qualify if:

• DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition.
• History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study.
• Clinically significant laboratory screening tests (including blood routine, biochemical tests)
• Pregnancy or lactation
• Inability to follow protocol

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Hsien-Yuan Lane, M.D., Ph.D

CONTACT

886 4 22052121; hylane@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 22, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TW (1)