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Cipralex® for Anxiety Disorders in Adolescents (CAP-E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293838
Recruitment Status : Unknown
Verified January 2011 by University of Ottawa.
Recruitment status was:  Recruiting
First Posted : February 11, 2011
Last Update Posted : February 11, 2011
H. Lundbeck A/S
Information provided by:
University of Ottawa

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE February 11, 2011
Last Update Posted Date February 11, 2011
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
Treatment Efficacy [ Time Frame: At week 16 ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • Physiological response to stress [ Time Frame: At week 18 - see below ]
    • 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 [ Time Frame: Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28) ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cipralex® for Anxiety Disorders in Adolescents
Official Title  ICMJE Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorder
Intervention  ICMJE Drug: Cipralex®

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

Other Name: Chemical/Pharmaceutical alternative name: Escitalopram
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01293838
Other Study ID Numbers  ICMJE IMHR REB#2007036
123485 ( Registry Identifier: Office of Clinical Trials, Health Canada )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Martine Flament, MD, PhD, FRCPC, Director of Youth Research Unit, University of Ottawa Institute of Mental Health Research
Study Sponsor  ICMJE University of Ottawa
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Martine Flament, MD University of Ottawa
PRS Account University of Ottawa
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP