MedTrace Logo

Cipralex® for Anxiety Disorders in Adolescents

NCT01293838 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-02-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Martine Flament, MD · University of Ottawa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293838 on ClinicalTrials.gov