A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
- Conditions
- Anxiety Disorders,Generalized Anxiety Disorder
- Interventions
- Other: Placebo
- Registration Number
- NCT03924323
- Lead Sponsor
- AbbVie
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram 10 mg/day Escitalopram Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Placebo Placebo Matching oral administration of placebo once daily
- Primary Outcome Measures
Name Time Method Change in Pediatric Anxiety Rating Scale (PARS) Severity Score Baseline to Week 8 The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (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) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
- Secondary Outcome Measures
Name Time Method Response Rate on the PARS Week 8 Response is defined as a 50% improvement on the PARS severity score for GAD
Remission Rate on the PARS 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) 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) 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.
Trial Locations
- Locations (39)
UH Cleveland Medical Center /ID# 233373
🇺🇸Cleveland, Ohio, United States
Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
🇺🇸Las Vegas, Nevada, United States
ATP Clinical Research, Inc /ID# 233362
🇺🇸Costa Mesa, California, United States
Woodland Research Northwest, LLC /ID# 233366
🇺🇸Rogers, Arkansas, United States
Indago Research and Health Cen /ID# 233364
🇺🇸Hialeah, Florida, United States
Psychiatric Associates /ID# 233360
🇺🇸Overland Park, Kansas, United States
Coastal Carolina Research Center /ID# 233344
🇺🇸North Charleston, South Carolina, United States
Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
🇺🇸Maitland, Florida, United States
Innovative Clinical Research /ID# 233365
🇺🇸Fort Lauderdale, Florida, United States
ProScience Research Group /ID# 233374
🇺🇸Culver City, California, United States
Medical Research Group of Central Florida /ID# 233357
🇺🇸Orange City, Florida, United States
Capstone Clinical Research /ID# 233354
🇺🇸Libertyville, Illinois, United States
Baber Research Group /ID# 233363
🇺🇸Naperville, Illinois, United States
CNS Healthcare - Jacksonville /ID# 233352
🇺🇸Jacksonville, Florida, United States
Manhattan Behavioral Medicine PLLC /ID# 233351
🇺🇸New York, New York, United States
Midwest Clinical Research Center /ID# 233346
🇺🇸Dayton, Ohio, United States
University of Cincinnati /ID# 233341
🇺🇸Cincinnati, Ohio, United States
Houston Clinical Trials /ID# 233345
🇺🇸Bellaire, Texas, United States
AIM Trials /ID# 233361
🇺🇸Plano, Texas, United States
CincyScience /ID# 233359
🇺🇸West Chester, Ohio, United States
Focus Center, PC /ID# 233349
🇺🇸Ogden, Utah, United States
Relaro Medical Trials /ID# 233369
🇺🇸Dallas, Texas, United States
Core Clinical Research /ID# 233353
🇺🇸Everett, Washington, United States
Northwest Clinical Research Center /ID# 233358
🇺🇸Bellevue, Washington, United States
Central States Research /ID# 233339
🇺🇸Tulsa, Oklahoma, United States
MCB Clinical Research Centers /ID# 233372
🇺🇸Colorado Springs, Colorado, United States
Quest Therapeutics of Avon Lake /ID# 233367
🇺🇸Avon Lake, Ohio, United States
Woodland International Research Group /ID# 233348
🇺🇸Little Rock, Arkansas, United States
Harmonex /ID# 233342
🇺🇸Dothan, Alabama, United States
Sun Valley Research Center /ID# 233343
🇺🇸Imperial, California, United States
Emerson Clinical Research Inst /ID# 233371
🇺🇸Washington, District of Columbia, United States
University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
🇺🇸Saint Petersburg, Florida, United States
Neuro-Behavioral Clinical Research, Inc. /ID# 233375
🇺🇸Canton, Ohio, United States
Alivation Research /ID# 233338
🇺🇸Lincoln, Nebraska, United States
SP Research, PLLC /ID# 233340
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Neuroscience Solutions, Inc /ID# 233350
🇺🇸Orlando, Florida, United States
APG Research, LLC /ID# 233337
🇺🇸Orlando, Florida, United States
Finger Lakes Clinical Research /ID# 233347
🇺🇸Rochester, New York, United States
University of Virginia /ID# 233370
🇺🇸Charlottesville, Virginia, United States