Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2008-03-31
2012-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Social Phobia
* Generalized Anxiety Disorder
* Separation Anxiety Disorder
* Panic Disorder
* Comorbid depression allowed
Exclusion Criteria
* Substance use disorder
* Current diagnosis of OCD
* Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis
13 Years
18 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
University of Ottawa
OTHER
Responsible Party
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University of Ottawa Institute of Mental Health Research
Principal Investigators
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Martine Flament, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Locations
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The University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1017/s1092852900020678.
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. doi: 10.1001/archpsyc.1996.01830120067012.
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. doi: 10.1097/00004583-199311000-00004.
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. doi: 10.1097/00004583-199607000-00012.
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. doi: 10.1001/archpsyc.1997.01830160049008.
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. doi: 10.1097/00004583-199009000-00013.
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. doi: 10.1037//0021-843x.102.1.133.
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. doi: 10.1001/archpsyc.62.6.593.
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. doi: 10.1111/j.1469-7610.1990.tb01565.x.
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. doi: 10.1097/00004583-200109000-00018.
Reinblatt SP, Walkup JT. Psychopharmacologic treatment of pediatric anxiety disorders. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):877-908, x. doi: 10.1016/j.chc.2005.06.004.
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. doi: 10.1097/00004583-199704000-00019.
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. doi: 10.1016/s1054-139x(01)00305-6.
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. doi: 10.1097/00004583-200209000-00006.
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. doi: 10.1001/archpsyc.55.1.56.
Other Identifiers
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123485
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMHR REB#2007036
Identifier Type: -
Identifier Source: org_study_id
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