Anxiety Disorders,Generalized Anxiety DisorderPhase 4NCT03924323
A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
A Phase 4 study testing Escitalopram in people with Anxiety Disorders,Generalized Anxiety Disorder, run by AbbVie at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety Disorders,Generalized Anxiety Disorder
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 39 sitesUnited States
- Study dates
- 30 May 2019to 20 Sep 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Quest Therapeutics of Avon Lake /ID# 233367
Avon Lake, Ohio, 44012
Houston Clinical Trials /ID# 233345
Bellaire, Texas, 77401-2928
Northwest Clinical Research Center /ID# 233358
Bellevue, Washington, 98007
Neuro-Behavioral Clinical Research, Inc. /ID# 233375
Canton, Ohio, 44720
University of Virginia /ID# 233370
Charlottesville, Virginia, 22903
University of Cincinnati /ID# 233341
Cincinnati, Ohio, 45219
UH Cleveland Medical Center /ID# 233373
Cleveland, Ohio, 44106
MCB Clinical Research Centers /ID# 233372
Colorado Springs, Colorado, 80910
ATP Clinical Research, Inc /ID# 233362
Costa Mesa, California, 92626-4607
ProScience Research Group /ID# 233374
Culver City, California, 90230-6632
Relaro Medical Trials /ID# 233369
Dallas, Texas, 75243
Midwest Clinical Research Center /ID# 233346
Dayton, Ohio, 45417
Harmonex /ID# 233342
Dothan, Alabama, 36303
Core Clinical Research /ID# 233353
Everett, Washington, 98201
Innovative Clinical Research /ID# 233365
Fort Lauderdale, Florida, 33319
Indago Research and Health Cen /ID# 233364
Hialeah, Florida, 33012-4170
Sun Valley Research Center /ID# 233343
Imperial, California, 92251-9401
CNS Healthcare - Jacksonville /ID# 233352
Jacksonville, Florida, 32256-6039
Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
Las Vegas, Nevada, 89128-0819
Capstone Clinical Research /ID# 233354
Libertyville, Illinois, 60048-5341
Alivation Research /ID# 233338
Lincoln, Nebraska, 68526-9474
Woodland International Research Group /ID# 233348
Little Rock, Arkansas, 72211
Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
Maitland, Florida, 32751
Baber Research Group /ID# 233363
Naperville, Illinois, 60563-6502
Manhattan Behavioral Medicine PLLC /ID# 233351
New York, New York, 10036
Coastal Carolina Research Center /ID# 233344
North Charleston, South Carolina, 29405
Focus Center, PC /ID# 233349
Ogden, Utah, 84405-4946
SP Research, PLLC /ID# 233340
Oklahoma City, Oklahoma, 73112-8729
Medical Research Group of Central Florida /ID# 233357
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc /ID# 233350
Orlando, Florida, 32801-2986
APG Research, LLC /ID# 233337
Orlando, Florida, 32803
Psychiatric Associates /ID# 233360
Overland Park, Kansas, 66221
AIM Trials /ID# 233361
Plano, Texas, 75093
Finger Lakes Clinical Research /ID# 233347
Rochester, New York, 14618-1609
Woodland Research Northwest, LLC /ID# 233366
Rogers, Arkansas, 72758-6442
University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
St. Petersburg, Florida, 33701-4708
Central States Research /ID# 233339
Tulsa, Oklahoma, 74136
Emerson Clinical Research Inst /ID# 233371
Washington D.C., District of Columbia, 20011
CincyScience /ID# 233359
West Chester, Ohio, 45069
About this study
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
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.
- Being tested
- Escitalopram, Placebo
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
8-weeks of treatment followed by 1-week taper down period
PlaceboOther
Matching oral administration of inactive substance once daily
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram 10 mg/day | Experimental | Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Matching oral administration of placebo once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
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.
Measured: Baseline to Week 8
Secondary outcomes (4)
Response Rate on the PARS
Response is defined as a 50% improvement on the PARS severity score for GAD
Measured: Week 8
Remission Rate on the PARS
Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)
Measured: Week 8
Change on the Clinical Global Impression of Severity (CGI-S)
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.
Measured: Week 8
Change on the Children's Global Assessment Scale (CGAS)
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start30 May 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders,Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924323
- Sponsor's protocol ID
- SCT-MD-60
- Status last verified
- Oct 2022
- First submitted
- 19 Apr 2019
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Strawn JR, Moldauer L, Hahn RD, Wise A, Bertzos K, Eisenberg B, Greenberg E, Liu C, Gopalkrishnan M, McVoy M, Knutson JA. A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder. J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 10.1089/cap.2023.0004.
PubMed 37074330
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03924323
- Acronym / sponsor ID
- SCT-MD-60
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram 10 mg/day | Experimental | Drug: EscitalopramOral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion |
| Placebo | Placebo comparator | Other: PlaceboMatching oral administration of placebo once daily |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram8-weeks of treatment followed by 1-week taper down period | Drug | Escitalopram 10 mg/day |
| PlaceboMatching oral administration of inactive substance once daily | Other | Placebo |
Primary outcome
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 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.
4 secondary outcomes
Response Rate on the PARS
Time frame: Week 8
Remission Rate on the PARS
Time frame: Week 8
Change on the Clinical Global Impression of Severity (CGI-S)
Time frame: Week 8
Change on the Children's Global Assessment Scale (CGAS)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37074330Strawn JR, Moldauer L, Hahn RD, Wise A, Bertzos K, Eisenberg B, Greenberg E, Liu C, Gopalkrishnan M, McVoy M, Knutson JA. A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder. J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 10.1089/cap.2023.0004.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Anxiety Disorders,Generalized Anxiety Disorder, run by AbbVie at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.