Anxiety Disorder | Cipralex® for Anxiety Disorders in Adolescents
Anxiety Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2008
Completed Date: January 2012
Phase: Phase 1
Primary Outcome: Treatment Efficacy
Secondary Outcome: Physiological response to stress
Study sponsors, principal investigator, and references
Principal Investigator: Martine Flament, MD
Lead Sponsor: University of Ottawa
Collaborator: H. Lundbeck A/S
Posner K, Melvin GA, Stanley B, Oquendo MA, Gould M. Factors in the assessment of suicidality in youth. CNS Spectr. 2007 Feb;12(2):156-62.