Recruiting
Phase 1

Cipralex

Sponsor:

University of Ottawa

Code:

NCT01293838

Conditions

Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Cipralex®

Study Details

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.

Conditions

Anxiety Disorder

Study ID

NCT01293838

Start date

Mar, 2008

Status verified date

Jan, 2011

Completion date

Jan, 2012

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Treatment Efficacy [ Time Frame: At week 16 ]

Central Contacts and Locations

Central contacts

Martine Flament, MD

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

Chantelle McEwen, MA

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

Locations

The University of Ottawa Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Chantelle McEwen, MA

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

Meagan Birmingham, MA

613-722-6521meagan.birmingham@rohcg.on.ca

Principal Investigator:

Martine Flament, MD

More Information

Sponsor

University of Ottawa

Last update posted

Feb 11, 2011

Last verified

Jan, 2011

Keywords

  • Adolescents
  • Anxiety Disorder
  • Cipralex
  • Social Phobia
  • Separation Anxiety Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder
  • physiological arousal
  • stress response
  • salivary cortisol
  • salivary alpha-amylase
  • heart rate variability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2011-02-11.