Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01293838
Status:
UNKNOWN
Last Update Posted:
2011-02-11
First Post:
2011-02-10
Brief Title:
Cipralex for Anxiety Disorders in Adolescents
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Cipralex for Anxiety Disorders in Adolescents Clinical and Physiological Changes Associated With Open Label Flexible-dose Treatment
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
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:
CAP-E
Brief Summary:
The primary objective is to examine whether Cipralex is effective and safe in the treatment of anxiety disorders in youth The secondary objective is to identify changes in arousal and stress response from pre- to post-treatment with Cipralex in youth with anxiety disorders
Detailed Description:
Anxiety disorders are the most common mental illnesses of adolescence with an overall prevalence ranging from 50 to 108 Costello et al 1996 Ford et al 2003 Fergusson et al 1993 Shaffer et al 1996 Verhulst et al 1997 Six- to 12-month prevalence has been estimated to be 05-24 for separation anxiety disorder SAD 21-46 for overanxious disorder OAD the DSM-III antecedent of generalized anxiety disorder GAD 17-69 for social phobia SP and 03-12 for panic disorder PD Bowen et al 1990 Fergusson et al 1993 Ford et al 2003 Lewinsohn et al 1993 Romano et al 2001 Verhulst et al 1997 In the US National Comorbidity Survey the median age of onset for anxiety disorders was 11 years range 6-21 years which was much younger than for substance use disorders 20 years and mood disorders 30 years Kessler 2005 However anxious youth often go undiagnosed and untreated possibly because they tend to be compliant and nondisruptive Esser et al 1990 This is of concern since research suggests that youth with untreated anxiety disorders are more likely to develop significant problems later in life such as continued anxiety depression substance abuse suicide attempts educational underachievement and impaired psychosocial functioning Pine et al 1998 Woodward Fergusson 2001
The existing literature on pharmacological treatment of anxiety disorders in adolescents is limited but suggests that the selective serotonin reuptake inhibitors SSRIs are the treatment of choice for pervasive and impairing anxiety disorders in youth Reinblatt Walkup 2005 A few randomized controlled trials RCT provide support for the use of SSRIs such as fluvoxamine and fluoxetine for the treatment of SAD GAD and SP Cipralex is a newer SSRI whose use for treatment of anxiety disorders in adolescents has been documented in only one previous open trial Isolan et al 2007 Results from this study and a few RCTs conducted in adults with anxiety disorders suggest that Cipralex should be effective and safe for relieving symptoms of anxiety in adolescents
Primary objectives 1 to assess the clinical and psychosocial changes associated with 16-week open-label treatment with Cipralex 10 to 20 mgday in adolescents with SAD SP PD andor GAD 2 to assess the tolerance and safety of Cipralex 10 to 20 mgday for 16 weeks in adolescents with SAD SP PD andor GAD
Secondary objective 1 to investigate changes in physiological measures of arousal and stress response ie heart rate variability salivary concentrations of cortisol and alpha-amylase acoustic startle response using standardized laboratory stressors before and after treatment with Cipralex 10 to 20 mgday for 16 weeks in youth with anxiety disorders
The existing literature on pharmacological treatment of anxiety disorders in adolescents is limited but suggests that the selective serotonin reuptake inhibitors SSRIs are the treatment of choice for pervasive and impairing anxiety disorders in youth Reinblatt Walkup 2005 A few randomized controlled trials RCT provide support for the use of SSRIs such as fluvoxamine and fluoxetine for the treatment of SAD GAD and SP Cipralex is a newer SSRI whose use for treatment of anxiety disorders in adolescents has been documented in only one previous open trial Isolan et al 2007 Results from this study and a few RCTs conducted in adults with anxiety disorders suggest that Cipralex should be effective and safe for relieving symptoms of anxiety in adolescents
Primary objectives 1 to assess the clinical and psychosocial changes associated with 16-week open-label treatment with Cipralex 10 to 20 mgday in adolescents with SAD SP PD andor GAD 2 to assess the tolerance and safety of Cipralex 10 to 20 mgday for 16 weeks in adolescents with SAD SP PD andor GAD
Secondary objective 1 to investigate changes in physiological measures of arousal and stress response ie heart rate variability salivary concentrations of cortisol and alpha-amylase acoustic startle response using standardized laboratory stressors before and after treatment with Cipralex 10 to 20 mgday for 16 weeks in youth with anxiety 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 123485 | REGISTRY | Office of Clinical Trials Health Canada | None |