Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02845349
Status:
WITHDRAWN
Last Update Posted:
2016-09-02
First Post:
2016-07-18
Brief Title:
Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury TBI
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Vortioxetine for the Treatment of Major Depression and Neuropsychiatric Co-morbidities After Traumatic Brain Injury TBI
Status:
WITHDRAWN
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traumatic brain injury TBI is a major public health problem with an annual incidence of about 17 million per year TBI is associated with various long-term morbidities Among them psychiatric disturbances are the major cause of chronic disability and poor quality of life Major depression is the common psychiatric sequela post TBI with rates ranging from 13 at 1 year to 60 at 8 years after TBI Major depression after TBI henceforth referred to as TBI depression is often associated with comorbid neuropsychiatric symptoms NPS such as anxiety aggression substance abuse and cognitive deficits that often makes treatment difficult Despite increased rates of depression there is no Food and Drug Administration FDA approved drugs for its treatment
The investigators propose to address these limitations by use of a novel serotonergic agent vortioxetine which has a multimodal mechanism of action through serotonin transporter SERT inhibition 5-hydroxytryptamine 5-HT3 7 and 1D receptor antagonism 1B receptor partial agonism and 1A receptor agonism
Overarching Goal The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS
Study Design The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression A total of 150 will be consented to allow for screen failures Written informed consent will be obtained from these patients Subjects will be followed for a total of 12 weeks Subjects will be randomized to either the vortioxetine arm N15 or placebo arm N15 The treatment group will receive vortioxetine 10mg per day which will be increased to 20 mg or decreased to 5 mg if deemed clinically necessary at week 4 or 8 Subjects will have a total of 4-5 visits Baseline evaluation 1 or 2 visits and follow-up visits at weeks 4 8 and 12 Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities If found to be effective results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging
The investigators propose to address these limitations by use of a novel serotonergic agent vortioxetine which has a multimodal mechanism of action through serotonin transporter SERT inhibition 5-hydroxytryptamine 5-HT3 7 and 1D receptor antagonism 1B receptor partial agonism and 1A receptor agonism
Overarching Goal The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS
Study Design The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression A total of 150 will be consented to allow for screen failures Written informed consent will be obtained from these patients Subjects will be followed for a total of 12 weeks Subjects will be randomized to either the vortioxetine arm N15 or placebo arm N15 The treatment group will receive vortioxetine 10mg per day which will be increased to 20 mg or decreased to 5 mg if deemed clinically necessary at week 4 or 8 Subjects will have a total of 4-5 visits Baseline evaluation 1 or 2 visits and follow-up visits at weeks 4 8 and 12 Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities If found to be effective results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging
Detailed Description:
In this study the investigators propose to recruit 30 outpatients with TBI of varying degrees of severity who also meet DSM 5 criteria for major depression The investigators will screen as many potential subjects as possible to get a total of 30 participants who meet the study criteria and complete the study Total 30 study completers Written informed consent will be obtained from all participants prior to collection of any data Participants will be evaluated using well validated psychiatric instruments Participants will be recruited from several sources 1 Brain Injury Clinic at Johns Hopkins Bayview Medical Center 2 referral from other Hopkins outpatient clinics 3 Brain injury support groups organized by the Brain Injury Association of Maryland and 4 Advertisements placed in local newspapers and 5 Trial Facts - an online recruiting source The study sites will be at the Geriatric Neuropsychiatry clinics at Johns Hopkins Bayview Medical Center
Overarching Goal The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid neuropsychiatric symptoms NPS
Study Design The study design will include a Double Blinded Placebo Controlled Trial DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression A total of 150 will be consented to allow for screen failures Written informed consent will be obtained from these patients Subjects will be followed for a total of 12 weeks Subjects will be randomized to either the vortioxetine arm N15 or placebo arm N15 The treatment group will receive vortioxetine 10mg per day which will be increased to 20 mg or decreased to 5 mg if deemed clinically necessary at week 4 or 8 Subjects will have a total of 4-5 visits Baseline evaluation 1 or 2 visits and follow-up visits at weeks 4 8 and 12
Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline for the treatment of major depression and its neuropsychiatric co-morbidities
Relevance This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities If found to be effective results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging Depression is common in other neurological disorders such as stroke multiple sclerosis Parkinsons disease and dementia syndromes Results from this study can shed light in the management of depression in other neurological disorders
Overarching Goal The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid neuropsychiatric symptoms NPS
Study Design The study design will include a Double Blinded Placebo Controlled Trial DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression A total of 150 will be consented to allow for screen failures Written informed consent will be obtained from these patients Subjects will be followed for a total of 12 weeks Subjects will be randomized to either the vortioxetine arm N15 or placebo arm N15 The treatment group will receive vortioxetine 10mg per day which will be increased to 20 mg or decreased to 5 mg if deemed clinically necessary at week 4 or 8 Subjects will have a total of 4-5 visits Baseline evaluation 1 or 2 visits and follow-up visits at weeks 4 8 and 12
Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline for the treatment of major depression and its neuropsychiatric co-morbidities
Relevance This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities If found to be effective results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging Depression is common in other neurological disorders such as stroke multiple sclerosis Parkinsons disease and dementia syndromes Results from this study can shed light in the management of depression in other neurological disorders
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