- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464383
Anxiety and Depression in Epilepsy: A Treatment Study
September 18, 2020 updated by: Wake Forest University Health Sciences
Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven 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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 or older
- Ability to take oral medication and the willing to adhere to the intervention regimen
- Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center
- Ability to complete questionnaires independently
- Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy
- (Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, GAD-7 score greater than or equal to 10
Exclusion Criteria:
- Pregnancy or lactation
- Known allergic reactions to escitalopram or venlafaxine
- Comorbid psychogenic nonepileptic seizures
- Prior psychiatric hospitalization
- Prior suicide attempt
- History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive)
- Current treatment by a psychiatrist or counselor/therapist
- Active suicidality at the time of screening
- Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Epileptologist-Driven Treatment
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).
|
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.
Other Names:
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ACTIVE_COMPARATOR: Standard of Care
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.
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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.
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OTHER: Survey Arm
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Intervention
Time Frame: 12 weeks
|
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)
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accrual
Time Frame: baseline
|
Percentage of patients screened for the trial who are eligible
|
baseline
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Participants Eligible for Consent Into Treatment Arms
Time Frame: baseline
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Percent eligible who consent to participate in treatment study
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baseline
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Retention
Time Frame: 12 weeks
|
Percentage of participants who complete the 12 week outcome assessment
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12 weeks
|
Efficacy - Depression Symptoms
Time Frame: baseline
|
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.
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baseline
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Efficacy - Depression Symptoms
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Efficacy - Anxiety Symptoms
Time Frame: baseline
|
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.
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baseline
|
Efficacy - Anxiety Symptoms
Time Frame: 12 weeks
|
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.
|
12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heidi Munger Clary, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 7, 2018
Primary Completion (ACTUAL)
September 20, 2019
Study Completion (ACTUAL)
September 20, 2019
Study Registration Dates
First Submitted
March 7, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (ACTUAL)
March 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Epilepsy
- Depression
- Depressive Disorder
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- IRB00048584
- 5UL1TR001420-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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