Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745143
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2021-01-14
Brief Title:
Monotherapy of an NMDA Enhancer for Schizophrenia
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Monotherapy of an NMDA Enhancer for Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Several lines of evidence suggest that schizophrenia is associated with accelerated aging and oxidative stress may play a role Cognitive deficits are core symptoms of accelerated aging in patients with schizophrenia and the most difficult domain to treat Current antipsychotics have limited if any efficacy for cognitive function Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing not only clinical symptoms but also 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 This study aims to examine the efficacy and safety of NMDAE monotherapy for the treatment of schizophrenia The investigators enroll patients with schizophrenia who refuse or are unable to tolerate antipsychotics due to poor response or adverse effects into a 6-week randomized double-blind trial to receive monotherapy of NMDAE or placebo The investigators biweekly measure clinical performances and side effects Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests The efficacies of NMDAE and placebo will be compared
Chi-square or Fishers exact test will be used to compare differences of categorical variables and t-test or Mann-Whitney test if the distribution is not normal for continuous variables between treatment groups Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation GEE All p values for clinical measures will be based on two-tailed tests with a significance level of 005
Chi-square or Fishers exact test will be used to compare differences of categorical variables and t-test or Mann-Whitney test if the distribution is not normal for continuous variables between treatment groups Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation GEE All p values for clinical measures will be based on two-tailed tests with a significance level of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None