AnxietyPhase 4PrEcISENCT04623099
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
A Phase 4 study testing Escitalopram in people with Anxiety, run by University of Cincinnati at 1 site in United States.
Trial summary
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written, informed assent and consent.
- Patients, parent/guardian must be fluent in the English.
- 12 to 17 years of age, inclusive, at Visit 1.
- Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID.
- PARS score ≥15 at Visit 1 and Visit 2.
- No initiation of psychotherapy within 8 weeks of screening (Visit 1). Current therapy much be stable for ≥2 months prior to baseline (Visit 2).
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- Clinical Global Impressions-Severity (CGI-S) score ≥4 at Visits 1 \& 2.
- Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
- No clinically significant abnormalities on physical examination and EKG.
- Negative pregnancy test at Visit 1 in females.
- Negative urine drug screen at Visit 1.
- Sexually active patients must practice a reliable method of contraception that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:
- Surgical sterilization
- Oral contraceptives (e.g. estrogen-progestin combination or progestin)
- Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
- Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
- An intrauterine device
- Diaphragm plus condom. -
Who cannot join
- Co-occurring DSM-5 mood disorder (except persistent depressive disorder, unspecified depressive disorder, provided that the primary diagnosis is an anxiety disorder), eating, bipolar or psychotic disorders.
- A lifetime diagnosis of an intellectual disability.
- A significant history of trauma exposure.
- A history of SSRI treatment within 12 weeks of baseline or current treatment with a medication with psychiatric effects that requires >5 half-lives for washout History of non-response to >2 SSRIs.
- Allergy, intolerance, non-response or hypersensitivity to escitalopram. Major neurological or medical illness or head trauma with ≥5 minutes loss of consciousness.
- Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
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- Psychotherapy initiated within 8 weeks of screening (Visit 1), or plans to initiate/change therapy during the study.
- Pregnant, breastfeeding, lactating, and/or planning to become pregnant during the study or within 30 days following the end of study participation.
- Positive urine pregnancy test.
- A positive urine drug screen.
- Patient lives >90 minutes from UC or unable to attend follow-up visits. Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.
- QTc >450 in males or >460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG
- Patients who are unable to swallow capsules.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, 45219
Zoe A Neptune, BS, 513-558-2866, neptunza@uc.edu
Heidi K Schroeder, BS, 513-558-4422, heysehk@uc.edu
About this study
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Read the detailed description
This randomized, controlled trial compares pharmacogenetically-guided and standard dosing of escitalopram in adolescents (12-17 years of age) with anxiety disorders. In this study, the investigators will examine these two dosing strategies in terms of efficacy (Aim 1) and tolerability (Aim 2).
The investigators propose to recruit 132 adolescents (age 12-17 years, inclusive) with generalized, separation and/or social anxiety disorder (pediatric anxiety trial).1 This will allow investigators to evaluate whether pharmacogenetically-guided escitalopram dosing improves efficacy and tolerability in outpatient adolescents aged 12-17 years with anxiety disorders. Eligible patients will be randomized to: (1) standard escitalopram dosing or (2) pharmacogenetically-guided dosing for 12 weeks.
- Conditions
- Anxiety
- Being tested
- Escitalopram
- Keywords
- Kids, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Escitalopram is FDA-approved for the treatment of major depressive disorder (MDD) in adolescents (12-17 years of age) and is commonly prescribed for adolescents with anxiety disorders.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing | Other | Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4. Receives: Drug: Escitalopram |
| Pharmacogenetically-guided escitalopram dosing | Experimental | Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anxiety Rating Scale severity score
Change from Baseline 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 in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)
Measured: Baseline to Week 12/Early Termination
Secondary outcomes (1)
Tolerability-Activation
Emergence of activation based on the Treatment-Emergent Activation and Suicidality Assessment Profile
Measured: Baseline to Week 12/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start8 Mar 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Model description
- This randomized, controlled trial compares pharmacogenetically-guided and standard dosing of escitalopram in adolescents (12-17 years of age) with anxiety disorders. In this study, investigators will examine these two dosing strategies in terms of efficacy (Aim 1) and tolerability (Aim 2). Investigators will also evaluate the relationship between pharmacodynamic variables and treatment response.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jeffrey Strawn, MD, University of Cincinnati
- Investigators
- Jeffrey R Strawn, MD, Principal investigator, University of CincinnatiLaura B Ramsey, PhD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623099
- Sponsor's protocol ID
- Strawn PrEcISE
- Other IDs
- R01HD099775
- Acronym
- PrEcISE
- Status last verified
- Aug 2024
- First submitted
- 4 Nov 2020
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strawn JR, Poweleit EA, Mills JA, Schroeder HK, Neptune ZA, Specht AM, Farrow JE, Zhang X, Martin LJ, Ramsey LB. Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial. J Pers Med. 2021 Nov 12;11(11):1188. doi: 10.3390/jpm11111188.
PubMed 34834540
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
- ClinicalTrials.gov ID
- NCT04623099
- Acronym / sponsor ID
- PrEcISE / Strawn PrEcISE
- Conditions
- Anxiety
- Keywords
- Kids, Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Detailed description
This randomized, controlled trial compares pharmacogenetically-guided and standard dosing of escitalopram in adolescents (12-17 years of age) with anxiety disorders. In this study, the investigators will examine these two dosing strategies in terms of efficacy (Aim 1) and tolerability (Aim 2).
The investigators propose to recruit 132 adolescents (age 12-17 years, inclusive) with generalized, separation and/or social anxiety disorder (pediatric anxiety trial).1 This will allow investigators to evaluate whether pharmacogenetically-guided escitalopram dosing improves efficacy and tolerability in outpatient adolescents aged 12-17 years with anxiety disorders. Eligible patients will be randomized to: (1) standard escitalopram dosing or (2) pharmacogenetically-guided dosing for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized, controlled trial compares pharmacogenetically-guided and standard dosing of escitalopram in adolescents (12-17 years of age) with anxiety disorders. In this study, investigators will examine these two dosing strategies in terms of efficacy (Aim 1) and tolerability (Aim 2). Investigators will also evaluate the relationship between pharmacodynamic variables and treatment response.
| Arm | Type | Receives |
|---|---|---|
| Standard dosing | Other | Drug: EscitalopramPatients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4. |
| Pharmacogenetically-guided escitalopram dosing | Experimental | Drug: EscitalopramPatients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Written, informed assent and consent.
- Patients, parent/guardian must be fluent in the English.
- 12 to 17 years of age, inclusive, at Visit 1.
- Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID.
- PARS score ≥15 at Visit 1 and Visit 2.
Key exclusion criteria (13 listed)
- Co-occurring DSM-5 mood disorder (except persistent depressive disorder, unspecified depressive disorder, provided that the primary diagnosis is an anxiety disorder), eating, bipolar or psychotic disorders.
- A lifetime diagnosis of an intellectual disability.
- A significant history of trauma exposure.
- A history of SSRI treatment within 12 weeks of baseline or current treatment with a medication with psychiatric effects that requires >5 half-lives for washout History of non-response to >2 SSRIs.
- Allergy, intolerance, non-response or hypersensitivity to escitalopram. Major neurological or medical illness or head trauma with ≥5 minutes loss of consciousness.
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 |
|---|---|---|
| EscitalopramAlso: LexaproEscitalopram is FDA-approved for the treatment of major depressive disorder (MDD) in adolescents (12-17 years of age) and is commonly prescribed for adolescents with anxiety disorders. | Drug | Pharmacogenetically-guided escitalopram dosing, Standard dosing |
Primary outcome
Pediatric Anxiety Rating Scale severity score
Time frame: Baseline to Week 12/Early Termination
Change from Baseline 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 in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)
1 secondary outcome
Tolerability-Activation
Time frame: Baseline to Week 12/Early Termination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Derived from this study: PubMed 34834540Strawn JR, Poweleit EA, Mills JA, Schroeder HK, Neptune ZA, Specht AM, Farrow JE, Zhang X, Martin LJ, Ramsey LB. Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial. J Pers Med. 2021 Nov 12;11(11):1188. doi: 10.3390/jpm11111188.
- Individual participant dataSharing planned: No
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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.
Jeffrey R Strawn, MD principal investigator
University of Cincinnati
Laura B Ramsey, PhD principal investigator
Children's Mercy Kansas City
1 site 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, run by University of Cincinnati at 1 site 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 18 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Neptune, BS ((513) 558-2866, neptunza@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anxiety Rating Scale severity score (time frame: Baseline to Week 12/Early Termination). 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 NCT04623099, 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 29 Aug 2024.