Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
1 other identifier
interventional
90
1 country
1
Brief Summary
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Nov 2020
Longer than P75 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2020
CompletedFirst Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 19, 2025
February 1, 2025
6 years
June 10, 2021
February 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Positive and Negative Syndrome Scale (PANSS)
Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.
week 0, 2, 4, 6, 9, 12
Secondary Outcomes (9)
Change of scales for the Assessment of Negative Symptoms (SANS) total score
week 0, 2, 4, 6, 9, 12
Positive subscale of PANSS
week 0, 2, 4, 6, 9, 12
Negative subscale of PANSS
week 0, 2, 4, 6, 9, 12
General Psychopathology subscale of PANSS
week 0, 2, 4, 6, 9, 12
Clinical Global Impression
week 0, 2, 4, 6, 9, 12
- +4 more secondary outcomes
Study Arms (2)
NMDAE plus Antioxidant agent (AO)
EXPERIMENTALAn NMDA enhancer plus a drug with antioxidant property
NMDAE plus Placebo
PLACEBO COMPARATORAn NMDA enhancer plus Placebo
Interventions
Use of an NMDA enhancer plus a drug with antioxidant property for the treatment of schizophrenia.
Eligibility Criteria
You may qualify if:
- Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
- PANSS total score ≥ 60
- Agree to participate in the study and provide informed consent
You may not qualify if:
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
June 10, 2021
First Posted
July 13, 2021
Study Start
November 30, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
February 19, 2025
Record last verified: 2025-02