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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Ottawa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT01293838
First received: February 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Drug: Cipralex®
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment

Resource links provided by NLM:


Further study details as provided by University of Ottawa:

Primary Outcome Measures:
  • Treatment Efficacy [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

    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 [ Time Frame: At week 18 - see below ] [ Designated as safety issue: No ]
    • 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) ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293838

Contacts
Contact: Martine Flament, MD 613-722-6521 ext 6455 martine.flament@rohcg.on.ca
Contact: Chantelle McEwen, MA 613-722-6521 ext 6194 chantelle.mcewen@rohcg.on.ca

Locations
Canada, Ontario
The University of Ottawa Institute of Mental Health Research Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Chantelle McEwen, MA    613-722-6521 ext 6194    chantelle.mcewen@rohcg.on.ca   
Contact: Meagan Birmingham, MA    613-722-6521 ext 7193    meagan.birmingham@rohcg.on.ca   
Principal Investigator: Martine Flament, MD         
Sponsors and Collaborators
University of Ottawa
H. Lundbeck A/S
Investigators
Principal Investigator: Martine Flament, MD University of Ottawa
  More Information

Publications:
Research Units for Pediatric Psychopharmacology. The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties.Journal of the American Academy of Child and Adolescent Psychiatry 41(9):1061-1069, 2002.

Responsible Party: Dr. Martine Flament, MD, PhD, FRCPC, Director of Youth Research Unit, University of Ottawa Institute of Mental Health Research
ClinicalTrials.gov Identifier: NCT01293838     History of Changes
Other Study ID Numbers: IMHR REB#2007036, 123485
Study First Received: February 10, 2011
Last Updated: February 10, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa:
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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 18, 2014