Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050804
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-12-19
Brief Title:
Evaluation of Stress Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Efficacy of an SSRI in Acute Stress Disorder and PTSD
Status:
COMPLETED
Status Verified Date:
2004-02
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:
The purpose of this study is to examine the short-term consequences of trauma and to determine the effectiveness of the drug sertraline in preventing and treating post-traumatic stress disorder PTSD and acute stress disorder ASD symptoms
ASD and PTSD are common consequences of exposure to traumatic events Despite growing evidence of neurobiological dysfunction in ASD and PTSD the origin of these disorders is still unknown This study will attempt to identify psychophysiological markers of ASD and find an effective treatment for its symptoms
Victims of serious motor vehicle collisions will be evaluated with clinical assessments and standardized questionnaires within 2 weeks after the accident Symptoms of exaggerated startle emotional reactivity to trauma-related and trauma-unrelated cues and cerebellum functioning will be evaluated Participants will be randomized to receive either sertraline or placebo an inactive sugar pill for 8 weeks Psychometric testing and psychological evaluations will be conducted 4 10 and 14 weeks after the accident and after a 2-week taper of the study medication
ASD and PTSD are common consequences of exposure to traumatic events Despite growing evidence of neurobiological dysfunction in ASD and PTSD the origin of these disorders is still unknown This study will attempt to identify psychophysiological markers of ASD and find an effective treatment for its symptoms
Victims of serious motor vehicle collisions will be evaluated with clinical assessments and standardized questionnaires within 2 weeks after the accident Symptoms of exaggerated startle emotional reactivity to trauma-related and trauma-unrelated cues and cerebellum functioning will be evaluated Participants will be randomized to receive either sertraline or placebo an inactive sugar pill for 8 weeks Psychometric testing and psychological evaluations will be conducted 4 10 and 14 weeks after the accident and after a 2-week taper of the study medication
Detailed Description:
Acute stress disorder ASD and posttraumatic stress disorder PTSD are common consequences of exposure to traumatic events Despite growing evidence of neurobiological dysfunction in ASD and PTSD the pathogenesis of these disorders is still unknown Drs Osuch and Ursano Uniformed Services University of the Health Sciences have received support to conduct a 14-week study that will investigate the efficacy of the serotonergic medication sertraline Zoloft in the treatment and prevention of posttraumatic psychiatric sequelae in ASD victims The present project is an amendment to Drs Osuch and Ursanos study It will attempt to identify early psychological and neurobiological abnormalities in ASD More specifically the present project will examine to what extent sensitization and conditioning processes as well as emotional dysregulation contribute to ASD We also propose to investigate the potential association between cerebellum dysfunction and peritraumatic dissociations To accomplish this goal a series of three experiments will be implemented to investigate 1 the symptom of exaggerated startle 2 emotional reactivity to trauma-related and trauma-unrelated cues and 3 cerebellum functioning using eyeblink conditioning This study will inform on the short-term consequences of trauma will help identify potential psychophysiological markers of ASD that emerge following trauma and will examine the effects of an SSRI on preventing trauma-related neurobiological deficits
We specifically propose to
1 Characterize psychophysiological responses in ASD victims shortly after trauma
2 Assess the effect of sertraline treatment on these psychophysiological responses
To accomplish aim 1 non-treated ASD victims will be compared to two control groups a non-ASD trauma group and a non-trauma healthy group The two control groups will be used to disentangle the effect of trauma from the effect of acute stress disorder To accomplish aim 2 the ASD sertraline group will be compared to the ASD placebo group following treatment
Forty victims of serious motor vehicle collision MVC with ASD will be recruited from a community hospital emergency room and evaluated with clinical assessments and standardized questionnaires within 2 weeks after the MVC The subjects will then be randomized to either sertraline or placebo for 8 weeks duration Psychometric testing and psychological evaluations will be conducted at 4 10 weeks post-MVC and after a 2-week taper of the medication and 2 more weeks 14 weeks post-MVC
We hypothesize that ASD patients will show
An enhancement or sensitization of baseline startle
An increase in autonomic arousal and in startle amplitude to trauma-related cues
A delayed eyeblink conditioning
Normalization of these deficits after sertraline treatment
This preliminary study is expected to lay the groundwork for a larger study of the early impact of traumatic events on psychophysiological and psychological processes In the long-term we expect to 1 better characterize the onset of symptoms and their evolution over time following trauma 2 identify psychophysiological markers for PTSD 3 identify ASD victims at-risk for PTSD and 4 improve our ability to prevent the development of chronic psychopathology following trauma
We specifically propose to
1 Characterize psychophysiological responses in ASD victims shortly after trauma
2 Assess the effect of sertraline treatment on these psychophysiological responses
To accomplish aim 1 non-treated ASD victims will be compared to two control groups a non-ASD trauma group and a non-trauma healthy group The two control groups will be used to disentangle the effect of trauma from the effect of acute stress disorder To accomplish aim 2 the ASD sertraline group will be compared to the ASD placebo group following treatment
Forty victims of serious motor vehicle collision MVC with ASD will be recruited from a community hospital emergency room and evaluated with clinical assessments and standardized questionnaires within 2 weeks after the MVC The subjects will then be randomized to either sertraline or placebo for 8 weeks duration Psychometric testing and psychological evaluations will be conducted at 4 10 weeks post-MVC and after a 2-week taper of the medication and 2 more weeks 14 weeks post-MVC
We hypothesize that ASD patients will show
An enhancement or sensitization of baseline startle
An increase in autonomic arousal and in startle amplitude to trauma-related cues
A delayed eyeblink conditioning
Normalization of these deficits after sertraline treatment
This preliminary study is expected to lay the groundwork for a larger study of the early impact of traumatic events on psychophysiological and psychological processes In the long-term we expect to 1 better characterize the onset of symptoms and their evolution over time following trauma 2 identify psychophysiological markers for PTSD 3 identify ASD victims at-risk for PTSD and 4 improve our ability to prevent the development of chronic psychopathology following trauma
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0036 | None | None | None |