Monotherapy of an NMDA Enhancer for Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NMDAE
- Placebo Cap
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
China Medical University Hospital
Lead sponsor
National Health Research Institutes, Taiwan
Collaborator
Source ClinicalTrials.gov