Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977023
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-07-28
Brief Title:
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
Status:
RECRUITING
Status Verified Date:
2023-10
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:
At present the treatment of Bipolar I disorder BD-I especially its depressive episode bipolar depression is still limited because there is no effective treatment for the associated cognitive impairment and perceived stress NMDA receptor NMDAR dysfunction is associated with BD-I particularly its cognitive impairment and perceived stress This study aims to examine the efficacy and safety of an NMDA enhancer NMDAE in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression
Detailed Description:
Bipolar I disorder BD-I is a severe brain disorder At present the treatment of BD-I especially its depressive episode bipolar depression is still limited because there is no effective treatment for the associated cognitive impairment and perceived stress This study aims to examine the efficacy and safety of an NMDA enhancer NMDAE in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression
The subjects are bipolar depression patients They have been treated for bipolar depression for at least four weeks but remain depressive Participating in this study they will continue the original treatment and will be randomized double-blindly to receive the NMDAE or placebo for 8 weeks We will measure 6 cognitive domains including 9 cognitive tests and quality of life at weeks 0 and 8 and assess the Perceived Stress Scale Global Assessment of Function GAF various scales for clinical symptoms and side effects at weeks 0 2 4 6 and 8
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
The subjects are bipolar depression patients They have been treated for bipolar depression for at least four weeks but remain depressive Participating in this study they will continue the original treatment and will be randomized double-blindly to receive the NMDAE or placebo for 8 weeks We will measure 6 cognitive domains including 9 cognitive tests and quality of life at weeks 0 and 8 and assess the Perceived Stress Scale Global Assessment of Function GAF various scales for clinical symptoms and side effects at weeks 0 2 4 6 and 8
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
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