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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Clinicaltrials.gov identifier NCT03924323

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted January 14, 2021

Study Description

Brief summary:

This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.

  • Condition or Disease:Anxiety Disorders
    Generalized Anxiety Disorder
  • Intervention/Treatment: Drug: Escitalopram
    Other: Placebo
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Escitalopram 10 mg/day
Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
Drug: Escitalopram
8-weeks of treatment followed by 1-week taper down period
Placebo Comparator: Placebo
Matching oral administration of placebo once daily
Other: Placebo
Matching oral administration of inactive substance once daily
Outcome Measures
  • Primary Outcome Measures: 1. Change in Pediatric Anxiety Rating Scale (PARS) severity score [ Time Frame: Baseline to Week 8 ]
    The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including GAD in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3 5, 6, and 7)
  • Secondary Outcome Measures: 1. Response rate on the PARS [ Time Frame: Week 8 ]
    Response is defined as a 50% improvement on the PARS severity score for GAD
  • 2. Remission rate on the PARS [ Time Frame: Week 8 ]
    Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)
  • 3. Change on the Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, Week 8 ]
    Remission rate on CGI-S at acute treatment endpoint (Week 8) Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
  • 4. Change on the Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, Week 8 ]
    Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS >70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning.
Eligibility Criteria
  • Ages Eligible for Study: 7 to 17 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Subject's parent/legal representative must give written informed consent, including
privacy authorization, prior to study participation. The subject will complete an
informed assent prior to study participation.

- Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established
by a comprehensive psychiatric evaluation and confirmed/supported using the
Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).

- Male subjects who are sexually active with a partner of childbearing potential must
use, with their partner, a condom plus an approved method of highly effective
contraception from the time of informed consent until 14 days after the last dose of
study drug.

- Female subjects who are sexually active and are of childbearing potential must use,
with their partner, an approved method of highly effective contraception from the time
of informed consent until 14 days after the last dose of study drug.

- Female subjects who are not of childbearing potential do not need to use any methods
of contraception. This includes preadolescent and adolescent females who have not
reached menarche.

- Subject must have venous access enough to allow blood sampling and be compliant with
blood draws as per the protocol.

Exclusion Criteria:

- Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime
diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic
disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct
disorder, oppositional defiant disorder, post-traumatic stress disorder, panic
disorder, or pervasive development disorder.

- Suspected or previously diagnosed intellectual disability disorder.

- One or more first-degree relatives with diagnosed bipolar I disorder.

- History of seizure disorder (other than febrile seizures).

- History of electroconvulsive therapy at any time during the subject's lifetime.

- Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of
the inactive ingredients or had frequent or severe allergic reactions to multiple
medications.

- Taking any medications that are contraindicated to escitalopram (escitalopram
oxalate).

- Inability to speak, read, or understand English well enough to complete the
assessments.

- No active suicidal ideation or lifetime history of suicidal behavior as assessed by
Columbia-Suicide Severity Rating Scale (C-SSRS).

Contacts and Locations
Contacts

Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
Show 39 Study Locations
Sponsors and Collaborators

Allergan

Investigators

Study Director: Arlene Lum Allergan

More Information
  • Responsible Party: Allergan
  • ClinicalTrials.gov Identifier: NCT03924323 History of Changes
  • Other Study ID Numbers: SCT-MD-60
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: January 14, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
  • Supporting Materials: Study Protocol, Clinical Study Report (CSR)
  • Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
  • Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
  • URL: http://www.allerganclinicaltrials.com/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Anxiety Disorders Disease