Clinical trial NCT01293838: Cipralex® for Anxiety Disorders in Adolescents
Official title: Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: 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
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2011-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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

Primary outcomes:
measure: Treatment Efficacy
timeFrame: At week 16
Secondary outcomes:
measure: Physiological response to stress
timeFrame: At week 18 - see below
measure: Suicide risk
timeFrame: Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Martine Flament, MD
role: PRINCIPAL_INVESTIGATOR
References:
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