Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574360
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
sigma-1 receptor S1R agonistic property have been tested in clinical trials for the treatment of schizophrenia In addition previous studies found that some NMDA receptor NMDAR-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia Whether combined treatment of an S1R agonist and an NMDA-enhancing agent can be better than an S1R agonist alone deserves study
Detailed Description:
The current treatment for schizophrenia remains unsatisfactory thus development of new treatments is vital Both sigma-1 receptor S1R dysfunction and NMDA receptor NMDAR hypofunction contribute to pathogenesis of schizophrenia especially treatment-resistant schizophrenia Several S1R agonists have been tested for its potential for schizophrenia treatment however its efficacy appears limited In addition previous studies also found that some NMDA-enhancing agents were able to augment efficacy of antipsychotics in the treatment of chronic schizophrenia Whether combined treatment of an S1R agonist and an NMDA-enhancer NMDAE can be better than an S1R agonist alone deserves study Therefore this study aims to compare an S1R agonist plus an NMDAE and an S1R agonist plus placebo in the treatment of treatment-resistant schizophrenia The subjects are the patients with treatment-resistant schizophrenia who have responded poorly to two or more kinds of antipsychotics treatment They keep their original treatment and are randomly double-blindly assigned into two treatment groups for 12 weeks 1 S1R agonist S1RA plus NMDAE or 2 S1RA plus placebo Clinical performances and side effects are measured at weeks 0 2 4 6 and 8 Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests The efficacies of S1RA plus NMDAE and S1RA plus 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None