Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258828
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2014-10-02
Brief Title:
An Open-Label Trial of Memantine for Cognitive Impairment in Patients With Post-Traumatic Stress Disorder
Sponsor:
Sriram Ramaswamy
Organization:
VA Nebraska Western Iowa Health Care System
Study Overview
Official Title:
An Open-Label Trial of Memantine for Cognitive Impairment in Patients With Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2020-05
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:
Twenty six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an open label fashion Cognition was assessed using the Spatial Span Logical Memory I and Letter-Number Sequencing subtests of the Wechsler Memory Scale III Third edition and the Repeatable Battery for the Assessment of Neuropsychological Status RBANS RBANS measures attention language visuospatial skills and immediate and delayed memories The Clinician Administered PTSD Scale CAPS Hamilton Depression Scale HAM-D Hamilton Anxiety Scale HAM-A Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q and Sheehan Disability Scale SDS were used to assess improvement in PTSD symptoms as secondary outcome measures
Detailed Description:
Participants were recruited from the Omaha Veterans Affairs Medical Center following local IRB approval We obtained written consent from all the subjects who were recruited in the study Veterans between the ages of 19 and 65 years with chronic PTSD diagnosis for 6 months attributable to military combat exposure were included in the study Patients were required to be clinically stable on their psychotropic medication regimen for at least three months prior to study entry In addition to meeting DSM-IV criteria for PTSD and endorsing subjective complaints of memory difficulties patients had to score least one standard deviation below the mean performance of a standardized age- and sex-matched population on the Spatial Span Logical Memory I and Letter-Number Sequencing subtests of the Wechsler Memory Scale III Third edition for study entry Patients with a history of dementia schizophrenia bipolar disorder traumatic brain injury and seizure were excluded Patients with any history of alcohol or illicit drug abuse or dependence within the past one month were excluded Patients requiring concomitant treatment with drugs with potential effects on the glutamergic system such as amantadinedextromethorphan or carbonic anhydrase inhibitors were excluded
Subjects initially received memantine 5 mg once daily which was increased weekly by 5 mgday in divided doses to a dose of 20 mgday Memory was assessed using the Repeatable Battery for the Assessment of Neuropsychological Status RBANS Randolph 1998 using both forms A and B at baseline end of week 8 and end of week 16 The RBANS is composed of 10 subtests that yield a total score and five index scores immediate memory visuospatialconstructional language attention and delayed memory Each index score has a normal mean of 100 and standard deviation of 15 based on the performance of a standardization sample matched to the US Census on sex ethnicity and level of education Alternative forms of the RBANS Forms A and B were used to avoid bias due to practice effects We administered Clinician Administered PTSD Scale CAPS Hamilton Depression Scale HAM-D Hamilton Anxiety Scale HAM-A Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q and Sheehan Disability Scale SDS to assess the secondary measures Changes in the scores over time with repeated measures were estimated with mixed-effects models The primary outcome measures of interest were index and percentile scores in RBANS total and subscale scores The repeated measures model included visit as a categorical variable as a fixed effect An unstructured covariance matrix was used to fit the within patient repeated measures effect Tukeys method was used to compare pair-wise means
Secondary outcome measures CAPS HAM-A HAM-D Q-LES-Q and SDS were analyzed similarly to the RBANS with repeated measures models P-values less than 005 are considered to be statistically significant SAS software version 91 SAS Institute Cary NC was used for the analysis
Subjects initially received memantine 5 mg once daily which was increased weekly by 5 mgday in divided doses to a dose of 20 mgday Memory was assessed using the Repeatable Battery for the Assessment of Neuropsychological Status RBANS Randolph 1998 using both forms A and B at baseline end of week 8 and end of week 16 The RBANS is composed of 10 subtests that yield a total score and five index scores immediate memory visuospatialconstructional language attention and delayed memory Each index score has a normal mean of 100 and standard deviation of 15 based on the performance of a standardization sample matched to the US Census on sex ethnicity and level of education Alternative forms of the RBANS Forms A and B were used to avoid bias due to practice effects We administered Clinician Administered PTSD Scale CAPS Hamilton Depression Scale HAM-D Hamilton Anxiety Scale HAM-A Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q and Sheehan Disability Scale SDS to assess the secondary measures Changes in the scores over time with repeated measures were estimated with mixed-effects models The primary outcome measures of interest were index and percentile scores in RBANS total and subscale scores The repeated measures model included visit as a categorical variable as a fixed effect An unstructured covariance matrix was used to fit the within patient repeated measures effect Tukeys method was used to compare pair-wise means
Secondary outcome measures CAPS HAM-A HAM-D Q-LES-Q and SDS were analyzed similarly to the RBANS with repeated measures models P-values less than 005 are considered to be statistically significant SAS software version 91 SAS Institute Cary NC was used for the analysis
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