Cipralex® for Anxiety Disorders in Adolescents (CAP-E)
Primary Purpose
Anxiety Disorder
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cipralex®
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Adolescents, Anxiety Disorder, Cipralex, Social Phobia, Separation Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder, physiological arousal, stress response, salivary cortisol, salivary alpha-amylase, heart rate variability
Eligibility Criteria
Inclusion Criteria:
- Primary diagnosis of (1 or more)
- Social Phobia
- Generalized Anxiety Disorder
- Separation Anxiety Disorder
- Panic Disorder
- Comorbid depression allowed
Exclusion Criteria:
- Unstable medical condition
- Substance use disorder
- Current diagnosis of OCD
- Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis
Sites / Locations
- The University of Ottawa Institute of Mental Health ResearchRecruiting
Outcomes
Primary Outcome Measures
Treatment Efficacy
Measures used to assess treatment efficacy:
The Anxiety Disorders Interview Schedule for DSM-IV, Research and Lifetime Version for Children and Parents (Silverman & Albano, 1996)
Multidimensional Anxiety Scale for Children (March et al., 1997)
Youth Quality of Life Scale (Topolski et al., 2001),
Pediatric Anxiety Rating Scale (RUPP, 2002)
Beck Depression Inventory-2 (Beck et al., 1996
Behavioral and Emotional Rating Scale-2 (Epstein & Sharma, 2004),
Clinical Global Impression Scale-Severity and Improvement (Guy, W. & ECDEU, 1976)
Secondary Outcome Measures
Physiological response to stress
Trier Social Stress Task for Children (TSST-C)[Baseline and week 18]
Salivary cortisol[For baseline, samples will be collected in the home upon awakening/8 am, +30, +60 min, at 4 pm, and at 8 pm on 2 consecutive weekdays. Cortisol will also be measured from samples collected before and after the TSST-C(-1, +10, +20, +30, +45, and +60 min)]
Salivary alpha-amylase[Before (-1), and +1, +10, +20, and +30 min after the TSST-C]
Heart rate variability[Baseline and during the TSST-C]
Acoustic Startle Response[Baseline and in a "fear-potentiated" condition with an ASR system]
Urine drug test
Suicide risk
At each treatment visit, the clinician will elicit AEs and SAEs, and complete the Columbia-Suicide Severity Rating Scale (C-SSRS) (Posner et al, 2007)
Full Information
NCT ID
NCT01293838
First Posted
February 10, 2011
Last Updated
February 10, 2011
Sponsor
University of Ottawa
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT01293838
Brief Title
Cipralex® for Anxiety Disorders in Adolescents
Acronym
CAP-E
Official Title
Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ottawa
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 5.0% to 10.8% (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 0.5-2.4% for separation anxiety disorder (SAD), 2.1-4.6% for overanxious disorder (OAD), the DSM-III antecedent of generalized anxiety disorder (GAD), 1.7-6.9% for social phobia (SP), and 0.3-1.2% 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 mg/day) in adolescents with SAD, SP, PD and/or GAD; (2) to assess the tolerance and safety of Cipralex® (10 to 20 mg/day for 16 weeks) in adolescents with SAD, SP, PD and/or GAD.
Secondary objective: (1) to investigate changes in physiological measures of arousal and stress response (i.e., 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 mg/day for 16 weeks) in youth with anxiety disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Adolescents, Anxiety Disorder, Cipralex, Social Phobia, Separation Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder, physiological arousal, stress response, salivary cortisol, salivary alpha-amylase, heart rate variability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cipralex®
Other Intervention Name(s)
Chemical/Pharmaceutical alternative name: Escitalopram
Intervention Description
Based on a starting rate of 5 mg/day, increased by 5 mg every 2 weeks to a maximum of 20 mg/day for weeks 7-16, each participant will receive up to:
10 mg tablets: 28
20 mg tablets: 84
Total for 30 participants:
10 mg tablets: 840
20 mg tablets: 2520
Continuation study for participants who respond to Cipralex - Across 12 weeks, each participant will receive up to:
*20 mg tablets: 84
Total for continuation study for all participants (assuming a 60% response rate, N=18):
*20 mg tablets: 1512
Primary Outcome Measure Information:
Title
Treatment Efficacy
Description
Measures used to assess treatment efficacy:
The Anxiety Disorders Interview Schedule for DSM-IV, Research and Lifetime Version for Children and Parents (Silverman & Albano, 1996)
Multidimensional Anxiety Scale for Children (March et al., 1997)
Youth Quality of Life Scale (Topolski et al., 2001),
Pediatric Anxiety Rating Scale (RUPP, 2002)
Beck Depression Inventory-2 (Beck et al., 1996
Behavioral and Emotional Rating Scale-2 (Epstein & Sharma, 2004),
Clinical Global Impression Scale-Severity and Improvement (Guy, W. & ECDEU, 1976)
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Physiological response to stress
Description
Trier Social Stress Task for Children (TSST-C)[Baseline and week 18]
Salivary cortisol[For baseline, samples will be collected in the home upon awakening/8 am, +30, +60 min, at 4 pm, and at 8 pm on 2 consecutive weekdays. Cortisol will also be measured from samples collected before and after the TSST-C(-1, +10, +20, +30, +45, and +60 min)]
Salivary alpha-amylase[Before (-1), and +1, +10, +20, and +30 min after the TSST-C]
Heart rate variability[Baseline and during the TSST-C]
Acoustic Startle Response[Baseline and in a "fear-potentiated" condition with an ASR system]
Urine drug test
Time Frame
At week 18 - see below
Title
Suicide risk
Description
At each treatment visit, the clinician will elicit AEs and SAEs, and complete the Columbia-Suicide Severity Rating Scale (C-SSRS) (Posner et al, 2007)
Time Frame
Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary diagnosis of (1 or more)
Social Phobia
Generalized Anxiety Disorder
Separation Anxiety Disorder
Panic Disorder
Comorbid depression allowed
Exclusion Criteria:
Unstable medical condition
Substance use disorder
Current diagnosis of OCD
Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine Flament, MD
Phone
613-722-6521
Ext
6455
Email
martine.flament@rohcg.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Chantelle McEwen, MA
Phone
613-722-6521
Ext
6194
Email
chantelle.mcewen@rohcg.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Flament, MD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Ottawa Institute of Mental Health Research
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantelle McEwen, MA
Phone
613-722-6521
Ext
6194
Email
chantelle.mcewen@rohcg.on.ca
First Name & Middle Initial & Last Name & Degree
Meagan Birmingham, MA
Phone
613-722-6521
Ext
7193
Email
meagan.birmingham@rohcg.on.ca
First Name & Middle Initial & Last Name & Degree
Martine Flament, MD
12. IPD Sharing Statement
Citations:
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Cipralex® for Anxiety Disorders in Adolescents
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