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
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: April 19, 2019
• First Posted Date: April 23, 2019
• Last Update Posted Date: January 14, 2021
• Actual Study Start Date: May 31, 2019
• Estimated Primary Completion Date: July 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2019)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 19, 2019)

• Response rate on the PARS [ Time Frame: Week 8 ]
  Response is defined as a 50% improvement on the PARS severity score for GAD
• 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)
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

• Drug: Escitalopram
  8-weeks of treatment followed by 1-week taper down period
• Other: Placebo
  Matching oral administration of inactive substance once daily

Study Arms

• Experimental: Escitalopram 10 mg/day
  Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
  Intervention: Drug: Escitalopram
• Placebo Comparator: Placebo
  Matching oral administration of placebo once daily
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 7, 2020): 300
• Original Estimated Enrollment (submitted: April 19, 2019): 256
• Estimated Study Completion Date: July 2, 2021
• Estimated Primary Completion Date: July 2, 2021 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03924323
• Other Study ID Numbers: SCT-MD-60
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: 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/

• Responsible Party: Allergan
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Arlene Lum; Allergan

• PRS Account: Allergan
• Verification Date: January 2021