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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
University of Ottawa
About
Eligibility
Locations
Outcomes
Full info

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

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 10, 2011
Last Updated
February 10, 2011
Sponsor
University of Ottawa
Collaborators
H. Lundbeck A/S
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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:
PubMed Identifier
17277716
Citation
Posner K, Melvin GA, Stanley B, Oquendo MA, Gould M. Factors in the assessment of suicidality in youth. CNS Spectr. 2007 Feb;12(2):156-62. doi: 10.1017/s1092852900020678.
Results Reference
background
PubMed Identifier
8956679
Citation
Costello EJ, Angold A, Burns BJ, Stangl DK, Tweed DL, Erkanli A, Worthman CM. The Great Smoky Mountains Study of Youth. Goals, design, methods, and the prevalence of DSM-III-R disorders. Arch Gen Psychiatry. 1996 Dec;53(12):1129-36. doi: 10.1001/archpsyc.1996.01830120067012.
Results Reference
background
PubMed Identifier
8282656
Citation
Fergusson DM, Horwood LJ, Lynskey MT. Prevalence and comorbidity of DSM-III-R diagnoses in a birth cohort of 15 year olds. J Am Acad Child Adolesc Psychiatry. 1993 Nov;32(6):1127-34. doi: 10.1097/00004583-199311000-00004.
Results Reference
background
PubMed Identifier
8768346
Citation
Shaffer D, Fisher P, Dulcan MK, Davies M, Piacentini J, Schwab-Stone ME, Lahey BB, Bourdon K, Jensen PS, Bird HR, Canino G, Regier DA. The NIMH Diagnostic Interview Schedule for Children Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA Study. Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry. 1996 Jul;35(7):865-77. doi: 10.1097/00004583-199607000-00012.
Results Reference
background
PubMed Identifier
9107149
Citation
Verhulst FC, van der Ende J, Ferdinand RF, Kasius MC. The prevalence of DSM-III-R diagnoses in a national sample of Dutch adolescents. Arch Gen Psychiatry. 1997 Apr;54(4):329-36. doi: 10.1001/archpsyc.1997.01830160049008.
Results Reference
background
PubMed Identifier
2228929
Citation
Bowen RC, Offord DR, Boyle MH. The prevalence of overanxious disorder and separation anxiety disorder: results from the Ontario Child Health Study. J Am Acad Child Adolesc Psychiatry. 1990 Sep;29(5):753-8. doi: 10.1097/00004583-199009000-00013.
Results Reference
background
PubMed Identifier
8436689
Citation
Lewinsohn PM, Hops H, Roberts RE, Seeley JR, Andrews JA. Adolescent psychopathology: I. Prevalence and incidence of depression and other DSM-III-R disorders in high school students. J Abnorm Psychol. 1993 Feb;102(1):133-44. doi: 10.1037//0021-843x.102.1.133. Erratum In: J Abnorm Psychol 1993 Nov;102(4):517.
Results Reference
background
PubMed Identifier
11383961
Citation
Romano E, Tremblay RE, Vitaro F, Zoccolillo M, Pagani L. Prevalence of psychiatric diagnoses and the role of perceived impairment: findings from an adolescent community sample. J Child Psychol Psychiatry. 2001 May;42(4):451-61.
Results Reference
background
PubMed Identifier
15939837
Citation
Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added].
Results Reference
background
PubMed Identifier
2312652
Citation
Esser G, Schmidt MH, Woerner W. Epidemiology and course of psychiatric disorders in school-age children--results of a longitudinal study. J Child Psychol Psychiatry. 1990 Jan;31(2):243-63. doi: 10.1111/j.1469-7610.1990.tb01565.x.
Results Reference
background
PubMed Identifier
11556633
Citation
Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018.
Results Reference
background
PubMed Identifier
16171707
Citation
Reinblatt SP, Walkup JT. Psychopharmacologic treatment of pediatric anxiety disorders. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):877-908, x. doi: 10.1016/j.chc.2005.06.004.
Results Reference
background
PubMed Identifier
18315447
Citation
Isolan L, Pheula G, Salum GA Jr, Oswald S, Rohde LA, Manfro GG. An open-label trial of escitalopram in children and adolescents with social anxiety disorder. J Child Adolesc Psychopharmacol. 2007 Dec;17(6):751-60. doi: 10.1089/cap.2007.0007.
Results Reference
background
PubMed Identifier
9100431
Citation
March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
Results Reference
background
PubMed Identifier
11728892
Citation
Topolski TD, Patrick DL, Edwards TC, Huebner CE, Connell FA, Mount KK. Quality of life and health-risk behaviors among adolescents. J Adolesc Health. 2001 Dec;29(6):426-35. doi: 10.1016/s1054-139x(01)00305-6.
Results Reference
background
Citation
Silverman, W. K. & Albano, A. M. (1996). The Anxiety Disorders Interview Schedule for DSM-IV-Child and Parent Versions. San Antonio, TX, Psychological Corporation.
Results Reference
background
Citation
Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Manual for the Beck Depression Inventory-2. San Antonio, TX: Psychological Corporation.
Results Reference
background
Citation
Epstein, M. H., & Sharma, J. M. (2004). Behavioral and Emotional Rating Scale-2: A strength-based approach to assessment. Austin, TX: PRO-ED.
Results Reference
background
Citation
Guy, W. & ECDEU (1976). Assessment Manual for Psychopharmacology. Early Clinical Drug Evaluation Unit.
Results Reference
background
PubMed Identifier
12218427
Citation
The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1061-9. doi: 10.1097/00004583-200209000-00006.
Results Reference
background
PubMed Identifier
9435761
Citation
Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
Results Reference
background

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Cipralex® for Anxiety Disorders in Adolescents

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