Monotherapy of an NMDA Enhancer for Schizophrenia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: National Health Research Institutes, Taiwan

Criteria

Inclusion Criteria:

• Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia

• Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects

• PANSS total score ≥ 60

• Free of antipsychotic drugs for at least 1 week

• Agree to participate in the study and provide informed consent

Exclusion Criteria:

• Current substance abuse or history of substance dependence in the past 3 months

• History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study

• Use of depot antipsychotic in the past 3 months;

• Clinically significant laboratory screening tests

• Pregnancy or lactation

• Inability to follow protocol