NCT01293838

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 11, 2011

Status Verified

January 1, 2011

Enrollment Period

3.8 years

First QC Date

February 10, 2011

Last Update Submit

February 10, 2011

Conditions

Anxiety Disorder

Keywords

AdolescentsAnxiety DisorderCipralexSocial PhobiaSeparation Anxiety DisorderPanic DisorderGeneralized Anxiety Disorderphysiological arousalstress responsesalivary cortisolsalivary alpha-amylaseheart rate variability

Outcome Measures

Primary Outcomes (1)

  • Treatment Efficacy

    Measures used to assess treatment efficacy: * The Anxiety Disorders Interview Schedule for DSM-IV, Research and Lifetime Version for Children and Parents (Silverman \& Albano, 1996) * Multidimensional Anxiety Scale for Children (March et al., 1997) * Youth Quality of Life Scale (Topolski et al., 2001), * Pediatric Anxiety Rating Scale (RUPP, 2002) * Beck Depression Inventory-2 (Beck et al., 1996 * Behavioral and Emotional Rating Scale-2 (Epstein \& Sharma, 2004), * Clinical Global Impression Scale-Severity and Improvement (Guy, W. \& ECDEU, 1976)

    At week 16

Secondary Outcomes (2)

  • Physiological response to stress

    At week 18 - see below

  • Suicide risk

    Each treatment visit (baseline then weeks 2, 4, 6, 8, 12, 16, 28)

Interventions

Cipralex®DRUG

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

Also known as: Chemical/Pharmaceutical alternative name: Escitalopram

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary diagnosis of (1 or more)
  • Social Phobia
  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
  • Panic Disorder
  • Comorbid depression allowed

You may not qualify if:

  • Unstable medical condition
  • Substance use disorder
  • Current diagnosis of OCD
  • Lifetime diagnosis of developmental delay, pervasive developmental disorder, psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

Related Publications (21)

  • 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.

    PMID: 17277716BACKGROUND

  • 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.

    PMID: 8956679BACKGROUND

  • 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.

    PMID: 8282656BACKGROUND

  • 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.

    PMID: 8768346BACKGROUND

  • 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.

    PMID: 9107149BACKGROUND

  • 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.

    PMID: 2228929BACKGROUND

  • 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.

    PMID: 8436689BACKGROUND

  • 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.

    PMID: 11383961BACKGROUND

  • 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.

    PMID: 15939837BACKGROUND

  • 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.

    PMID: 2312652BACKGROUND

  • 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.

    PMID: 11556633BACKGROUND

  • 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.

    PMID: 16171707BACKGROUND

  • 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.

    PMID: 18315447BACKGROUND

  • 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.

    PMID: 9100431BACKGROUND

  • 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.

    PMID: 11728892BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 12218427BACKGROUND

  • 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.

    PMID: 9435761BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPhobia, SocialAnxiety, SeparationPanic DisorderGeneralized Anxiety DisorderFractures, Stress

Interventions

Dexetimide

Condition Hierarchy (Ancestors)

Mental DisordersPhobic DisordersNeurodevelopmental DisordersFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

PiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martine Flament, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Flament, MD

CONTACT

613-722-6521martine.flament@rohcg.on.ca

Chantelle McEwen, MA

CONTACT

613-722-6521chantelle.mcewen@rohcg.on.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

March 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 11, 2011

Record last verified: 2011-01

Locations

CA(1)