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Cipralex® for Anxiety Disorders in Adolescents

Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorder

Intervention: Cipralex® (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Ottawa

Official(s) and/or principal investigator(s):
Martine Flament, MD, Principal Investigator, Affiliation: University of Ottawa

Overall contact:
Martine Flament, MD, Phone: 613-722-6521, Ext: 6455, Email: martine.flament@rohcg.on.ca

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment Efficacy

Secondary outcome:

Physiological response to stress

Suicide risk

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

Minimum age: 13 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Martine Flament, MD, Phone: 613-722-6521, Ext: 6455, Email: martine.flament@rohcg.on.ca

The University of Ottawa Institute of Mental Health Research, Ottawa, Ontario K1Z 7K4, Canada; Recruiting
Chantelle McEwen, MA, Phone: 613-722-6521, Ext: 6194, Email: chantelle.mcewen@rohcg.on.ca
Meagan Birmingham, MA, Phone: 613-722-6521, Ext: 7193, Email: meagan.birmingham@rohcg.on.ca
Martine Flament, MD, Principal Investigator
Additional Information

Related publications:

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.

Costello EJ, Angold A, Burns BJ, Stangl DK, Tweed DL, Erkanli A, Worthman CM. The Great Smoky Mountains Study of Youth. Goals, design, methods, and the prevalence of DSM-III-R disorders. Arch Gen Psychiatry. 1996 Dec;53(12):1129-36.

Fergusson DM, Horwood LJ, Lynskey MT. Prevalence and comorbidity of DSM-III-R diagnoses in a birth cohort of 15 year olds. J Am Acad Child Adolesc Psychiatry. 1993 Nov;32(6):1127-34.

Shaffer D, Fisher P, Dulcan MK, Davies M, Piacentini J, Schwab-Stone ME, Lahey BB, Bourdon K, Jensen PS, Bird HR, Canino G, Regier DA. The NIMH Diagnostic Interview Schedule for Children Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA Study. Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry. 1996 Jul;35(7):865-77.

Verhulst FC, van der Ende J, Ferdinand RF, Kasius MC. The prevalence of DSM-III-R diagnoses in a national sample of Dutch adolescents. Arch Gen Psychiatry. 1997 Apr;54(4):329-36.

Bowen RC, Offord DR, Boyle MH. The prevalence of overanxious disorder and separation anxiety disorder: results from the Ontario Child Health Study. J Am Acad Child Adolesc Psychiatry. 1990 Sep;29(5):753-8.

Lewinsohn PM, Hops H, Roberts RE, Seeley JR, Andrews JA. Adolescent psychopathology: I. Prevalence and incidence of depression and other DSM-III-R disorders in high school students. J Abnorm Psychol. 1993 Feb;102(1):133-44. Erratum in: J Abnorm Psychol 1993 Nov;102(4):517.

Romano E, Tremblay RE, Vitaro F, Zoccolillo M, Pagani L. Prevalence of psychiatric diagnoses and the role of perceived impairment: findings from an adolescent community sample. J Child Psychol Psychiatry. 2001 May;42(4):451-61.

Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. Erratum in: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added].

Esser G, Schmidt MH, Woerner W. Epidemiology and course of psychiatric disorders in school-age children--results of a longitudinal study. J Child Psychol Psychiatry. 1990 Jan;31(2):243-63.

Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93.

Reinblatt SP, Walkup JT. Psychopharmacologic treatment of pediatric anxiety disorders. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):877-908, x. Review.

Isolan L, Pheula G, Salum GA Jr, Oswald S, Rohde LA, Manfro GG. An open-label trial of escitalopram in children and adolescents with social anxiety disorder. J Child Adolesc Psychopharmacol. 2007 Dec;17(6):751-60. doi: 10.1089/cap.2007.0007.

March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65.

Topolski TD, Patrick DL, Edwards TC, Huebner CE, Connell FA, Mount KK. Quality of life and health-risk behaviors among adolescents. J Adolesc Health. 2001 Dec;29(6):426-35.

Silverman, W. K. & Albano, A. M. (1996). The Anxiety Disorders Interview Schedule for DSM-IV—Child and Parent Versions. San Antonio, TX, Psychological Corporation.

Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Manual for the Beck Depression Inventory-2. San Antonio, TX: Psychological Corporation.

Epstein, M. H., & Sharma, J. M. (2004). Behavioral and Emotional Rating Scale-2: A strength-based approach to assessment. Austin, TX: PRO-ED.

Guy, W. & ECDEU (1976). Assessment Manual for Psychopharmacology. Early Clinical Drug Evaluation Unit.

The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1061-9.

Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64.

Starting date: March 2008
Last updated: February 10, 2011

Page last updated: August 23, 2015

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