Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395213
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2006-10-31
Brief Title:
Antidepressant Safety in Kids Study
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Antidepressant Safety in Kids ASK Study An Open-label Prospective Cohort Study of Antidepressants in Children and Adolescents With Anxiety Disorders Depressive Disorders Eating Disorders or Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2015-04
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:
ASK
Brief Summary:
This study will evaluate the risks and benefits of treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents with a pre-specified anxiety disorder depressive disorder eating disorder or obsessive-compulsive disorder
Detailed Description:
The Antidepressant Safety in Kids ASK study is part of the Child and Adolescent Psychiatry Trials Network CAPTN
Selective serotonin reuptake inhibitor SSRI and serotonin-norepinephrine reuptake inhibitor SNRI medications are prescribed to approximately 2 to 3 of American children Evidence suggests that these medications are beneficial for treating obsessive-compulsive disorder OCD anxiety disorders and major depressive disorder Following hearings in February and September of 2004 the FDA mandated Black Box warnings for all antidepressants cautioning prescribers about the risk of treatment-emergent suicidal tendency in children and adolescents treated with these drugs Although prescribing waned somewhat following the warning many children continue to receive SSRIs and SNRIs for a variety of conditions that do not have empirically validated alternative treatments Therefore there is a pressing need to clearly understand the safety tolerability and effectiveness of SSRIs and SNRIs in children and adolescents
Specific Aim
The purpose of this study is to evaluate the safety tolerability and effectiveness of SSRI and SNRI medications for children and adolescents with anxiety disorders depressive disorders eating disorders or obsessive-compulsive disorder The study will characterize predictors of outcome including demographic disease severity comorbidity concomitant treatment and genetic variation This information will help clinicians to better understand the balance of risk and benefit associated with antidepressants and to answer the question of which treatment is best for which child
Three specific aims include the following
1 To evaluate the within-subject benefit of antidepressant treatment over acute 12 weeks and maintenance an additional 6 months of treatment
2 To evaluate the adverse event profile for harm to self harm to others and psychiatric and nonpsychiatric adverse events
3 To evaluate potential moderators and mediators of benefits and adverse events
Design
This will be a prospective longitudinal cohort study of 2420 consecutively enrolled patients who are prescribed an SSRI or SNRI Citalopram Celexa Escitalopram Lexapro Fluoxetine ProzacProzac Weekly Fluvoxamine Luvox Paroxetine PaxilPaxil-Cr Sertraline Zoloft Venlafaxine EffexorEffexor XR Duloxetine Cymbalta Patients will be drawn from the practices of approximately 200 CAPTN participants in the United States and Canada
Study Timeline
This study will have two phases 1 an acute treatment phase following initiation of treatment with any SSRI or SNRI of the clinicians choosing and 2 a long-term follow-up phase The acute treatment phase will last 12 weeks and the long-term follow-up phase will occur 6 and 9 months after initiation of treatment
Treatment
Flexible upward titration of any of the commercially available SSRI or SNRI medications As decided by the treating doctor titration will depend on the severity of illness degree of response and adverse event profile With few exceptions concomitant treatments are permitted
Assessment
Study assessment milestones will occur at baseline Week 12 and Months 6 and 9 or at study entry CAPTN uses a no query rule electronic data capture system The parent and child will complete a pen and paper workbook consisting primarily of the DISC Predictive Scales DPS-IV and the Pediatric Adverse Event Rating Scale PAERS Based on this information and on clinical interview the treating clinician will complete the fully web-based EDC modules at baseline and at all treatment and end-of-study visits
Selective serotonin reuptake inhibitor SSRI and serotonin-norepinephrine reuptake inhibitor SNRI medications are prescribed to approximately 2 to 3 of American children Evidence suggests that these medications are beneficial for treating obsessive-compulsive disorder OCD anxiety disorders and major depressive disorder Following hearings in February and September of 2004 the FDA mandated Black Box warnings for all antidepressants cautioning prescribers about the risk of treatment-emergent suicidal tendency in children and adolescents treated with these drugs Although prescribing waned somewhat following the warning many children continue to receive SSRIs and SNRIs for a variety of conditions that do not have empirically validated alternative treatments Therefore there is a pressing need to clearly understand the safety tolerability and effectiveness of SSRIs and SNRIs in children and adolescents
Specific Aim
The purpose of this study is to evaluate the safety tolerability and effectiveness of SSRI and SNRI medications for children and adolescents with anxiety disorders depressive disorders eating disorders or obsessive-compulsive disorder The study will characterize predictors of outcome including demographic disease severity comorbidity concomitant treatment and genetic variation This information will help clinicians to better understand the balance of risk and benefit associated with antidepressants and to answer the question of which treatment is best for which child
Three specific aims include the following
1 To evaluate the within-subject benefit of antidepressant treatment over acute 12 weeks and maintenance an additional 6 months of treatment
2 To evaluate the adverse event profile for harm to self harm to others and psychiatric and nonpsychiatric adverse events
3 To evaluate potential moderators and mediators of benefits and adverse events
Design
This will be a prospective longitudinal cohort study of 2420 consecutively enrolled patients who are prescribed an SSRI or SNRI Citalopram Celexa Escitalopram Lexapro Fluoxetine ProzacProzac Weekly Fluvoxamine Luvox Paroxetine PaxilPaxil-Cr Sertraline Zoloft Venlafaxine EffexorEffexor XR Duloxetine Cymbalta Patients will be drawn from the practices of approximately 200 CAPTN participants in the United States and Canada
Study Timeline
This study will have two phases 1 an acute treatment phase following initiation of treatment with any SSRI or SNRI of the clinicians choosing and 2 a long-term follow-up phase The acute treatment phase will last 12 weeks and the long-term follow-up phase will occur 6 and 9 months after initiation of treatment
Treatment
Flexible upward titration of any of the commercially available SSRI or SNRI medications As decided by the treating doctor titration will depend on the severity of illness degree of response and adverse event profile With few exceptions concomitant treatments are permitted
Assessment
Study assessment milestones will occur at baseline Week 12 and Months 6 and 9 or at study entry CAPTN uses a no query rule electronic data capture system The parent and child will complete a pen and paper workbook consisting primarily of the DISC Predictive Scales DPS-IV and the Pediatric Adverse Event Rating Scale PAERS Based on this information and on clinical interview the treating clinician will complete the fully web-based EDC modules at baseline and at all treatment and end-of-study visits
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 |
|---|---|---|---|
| P30MH066386 | NIH | None | None |
| DSIR CTM | None | None | None |
| 3159 8067-06-1 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30MH066386 |