NCT01293838

Cipralex® for Anxiety Disorders in Adolescents

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Ottawa · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-02-11
• Last updated: 2011-02-11

Locations

1 site across 1 country: Canada