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NCT03464383 · ClinicalTrials.gov registry record · Phase 4
Anxiety and Depression in Epilepsy: A Treatment Study
A Phase 4 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
NCT03464383: Completed Phase 4 study, sponsored by Wake Forest University Health Sciences.
NCT03464383 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03464383, a Phase 4 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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)
Interventions
- DRUG Escitalopram 10mg
- OTHER Referral to Psychiatry
- OTHER Survey only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2019-09-20 |
| Phase | Phase 4 |
What the finished NCT03464383 record still lists
NCT03464383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Escitalopram 10mg is the first listed.
NCT03464383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03464383 about?
NCT03464383 is a clinical study titled "Anxiety and Depression in Epilepsy: A Treatment Study". 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...
What is the current status of trial NCT03464383?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2018-05-07. Estimated completion is 2019-09-20.
What interventions are being tested in trial NCT03464383?
The interventions under investigation include: Escitalopram 10mg (DRUG), Referral to Psychiatry (OTHER), Survey only (OTHER).
Who is sponsoring clinical trial NCT03464383?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03464383's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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