A Phase 4 interventional study of Escitalopram 10mg and Referral to Psychiatry in Anxiety, Depression and Epilepsy, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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Among 108 studies testing escitalopram in Depression — 6 open to participants now, 7 under way, none of them phase 3. Escitalopram · Depression.
Among the 108 studies testing escitalopram in Depression, this one is the 69th largest by enrollment, is one of 3 that started in 2018, is one of 54 in phase 4, and was the 96th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →6 of the 108 studies testing escitalopram in Depression are open now, in 5 countries. Recruiting first, the newest first:
Peking University · Sites in China
Ages 18–65
Poznan University of Medical Sciences · Sites in Poland
Ages 12+
Medical University of Vienna · Sites in Austria
Ages 18–65 · Healthy volunteers
Chonnam National University Hospital · Sites in Korea, Republic of
Ages 19–65
University of Cincinnati · Sites in United States
Ages 18–50
By country, each count listing its studies:
Escitalopram: first FDA approval 2002 (LEXAPRO). What it is approved for, and how studies give it, is on its page →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
108 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 10 · Phase 3 29 · Phase 4 54
First in 2001; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 69 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 107 across the 108 interventional studies. Of the 86 that completed or were terminated, 49 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 108 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
39 studies in Depression by Wake Forest University Health Sciences: 6 open now, 7 under way, none of them phase 3. Of 29 finished, 15 (52%) have results posted.
Among the 39 studies in Depression by Wake Forest University Health Sciences, this one is the 11th largest by enrollment of the 33 interventional ones that give a count, is one of 3 that started in 2018, is one of 5 in phase 4, and was the 16th registered.
Wake Forest University Health Sciences’s Depression studies by the year they started, since 2001.
3 of the studies testing escitalopram in Depression that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06675851Medical University of ViennaReward-specific Changes of the Chemical Messenger Dopamine in the Brain of Healthy and Depressed People | 2026-12 |
| NCT07480525Peking UniversityEfficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder | 2026-12-31 |
| NCT07478796Poznan University of Medical SciencesTDM-Guided Treatment With SSRIs in Hospitalized Adults and Children | 2027-11-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 108 studies testing escitalopram in Depression, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Wake Forest University Health Sciences’s 39 in Depression:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. Patients that do not meet eligibility requirement or decline the study intervention will have the option of participating in the survey arm of the study. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist. Participants in the survey arm of the study will complete a one time survey.
This trial is an innovative learning healthcare system approach to translate the concept of measurement-based depression care into a specialty clinic setting and extend the concept to treat depression and/or anxiety. The investigators' neurologist/APP-administered medication intervention utilizes FDA-approved drugs with advantageous features for use in epilepsy (escitalopram and venlafaxine) and a telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The proposed intervention may overcome barriers to implementing mental health treatment interventions in generalized clinical settings by using healthcare providers commonly present in specialty clinics (physicians and APPs) along with a billable, best practices chronic care management intervention package and EMR-based clinical tools.To test this idea, the investigators seek to pilot a randomized trial of neurologist/APP medication management of depression and anxiety versus usual care with psychiatry referral in the epilepsy clinic, using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity. The optional survey arm is to help investigators understand the population that do not meet criteria or refuse intervention.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 69 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose adjustment will be made based on biweekly repeated screening of anxiety and depression symptoms, as well as side effects identified on biweekly telephone calls or the 6-week advanced practice provider (APP) follow up visit. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
Drug: Escitalopram 10mg
A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.
Other: Referral to Psychiatry
This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.
Other: Survey only
Participants will be given escitalopram 10mg by mouth daily and will be followed up with at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.
Also known as: Lexapro
Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.
One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.
Adherence to Intervention
Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)
Time frame: 12 weeks
Accrual
Percentage of patients screened for the trial who are eligible
Time frame: baseline
Participants Eligible for Consent Into Treatment Arms
Percent eligible who consent to participate in treatment study
Time frame: baseline
Retention
Percentage of participants who complete the 12 week outcome assessment
Time frame: 12 weeks
Efficacy - Depression Symptoms
Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
Time frame: baseline
Efficacy - Depression Symptoms
Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
Time frame: 12 weeks
Efficacy - Anxiety Symptoms
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
Time frame: baseline
Efficacy - Anxiety Symptoms
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
Time frame: 12 weeks
| Milestone | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Started | 3 | 3 | 63 |
| Completed | 2 | 2 | 63 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)
| Participants | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Adherence to Intervention | 2 | 0 | 0 |
Percentage of patients screened for the trial who are eligible
| Participants | Epileptologist-Driven Treatment Plus Standard of Care Arm |
|---|---|
| Accrual | 19 |
Percent eligible who consent to participate in treatment study
| Participants | Epileptologist-Driven Treatment Plus Standard of Care Arm |
|---|---|
| Participants Eligible for Consent Into Treatment Arms | 6 |
Percentage of participants who complete the 12 week outcome assessment
| Participants | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Retention | 2 | 2 | 0 |
Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
| score on a scale | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Efficacy - Depression Symptoms | 26.7 ± 3.5 | 21.0 ± 7.2 | — |
Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome.
| score on a scale | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Efficacy - Depression Symptoms | 25.0 ± 5.7 | 17.0 ± 8.5 | — |
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
| score on a scale | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Efficacy - Anxiety Symptoms | 18.0 ± 9.6 | 10.5 ± 2.1 | — |
Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes.
| score on a scale | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| Efficacy - Anxiety Symptoms | 9.5 ± 9.2 | 11 | — |
Collected over Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epileptologist-Driven Treatment | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Standard of Care | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Survey Arm | 1/63 (1.6%) | 1/63 (1.6%) | 0/63 (0%) |
| Event | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| sudden unexpected death in epilepsyNervous system disorders | 0/3 | 0/3 | 1/63 |
| Event | Epileptologist-Driven Treatment | Standard of Care | Survey Arm |
|---|---|---|---|
| tooth pain from impacted wisdom toothMusculoskeletal and connective tissue disorders | 0/3 | 1/3 | 0/63 |
| diarrheaGastrointestinal disorders | 1/3 | 0/3 | 0/63 |
| sexual dysfunctionReproductive system and breast disorders | 1/3 | 0/3 | 0/63 |
| tremorNervous system disorders | 1/3 | 0/3 | 0/63 |
| night sweatsEndocrine disorders | 1/3 | 0/3 | 0/63 |
| headacheNervous system disorders | 0/3 | 1/3 | 0/63 |
| Age, Categorical(Participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 61 | 67 |
| >=65 years | 0 | 0 | 2 | 2 |
| Age, Continuous(years) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| Mean | 39.0 ± 6.1 | 41.3 ± 4.0 | 42.2 ± 13.5 | 42.0 ± 13.0 |
| Sex: Female, Male(Participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 40 | 42 |
| Male | 2 | 2 | 23 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 4 | 4 |
| Not Hispanic or Latino | 3 | 3 | 47 | 53 |
| Unknown or Not Reported | 0 | 0 | 12 | 12 |
| Race (NIH/OMB)(Participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 9 | 10 |
| White | 3 | 2 | 48 | 53 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 4 | 4 |
| Race and Ethnicity Not Collected(Participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Epileptologist-Driven Treatment | Standard of Care | Survey Arm | Total |
|---|---|---|---|---|
| United States | 3 | 3 | 63 | 69 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Sep 2019, 16 months.
Results were first posted in Oct 2020, 1 year after primary completion.
Of 110 non-industry phase 4 interventional studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's 16 months is below that.
Counting every sponsor, half of 119 studies reached it within 32 months; a quarter within 17 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Escitalopram
Wake Forest University Health Sciences →