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Trial record 84 of 582 for:    ESCITALOPRAM

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

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ClinicalTrials.gov Identifier: NCT03924323
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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 Intervention/treatment Phase
Anxiety Disorders Generalized Anxiety Disorder Drug: Escitalopram Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 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
Estimated Study Start Date : May 21, 2019
Estimated Primary Completion Date : July 4, 2021
Estimated Study Completion Date : July 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




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.



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Ages Eligible for Study:   7 Years 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924323


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

Sponsors and Collaborators
Allergan
Investigators
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Study Director: Arlene Lum Allergan

Additional Information:
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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: April 23, 2019
Last Verified: April 2019
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/

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

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents