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

February 10, 2011 updated by: University of Ottawa

Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 7K4
        • Recruiting
        • The University of Ottawa Institute of Mental Health Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martine Flament, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 18 - see below
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)
Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Martine Flament, MD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMHR REB#2007036
  • 123485 (Registry Identifier: Office of Clinical Trials, Health Canada)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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