- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522987
Anxiety and Depression in Epilepsy: A Pilot Treatment Study
September 11, 2019 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 trial aims to carry out treatment for depression and anxiety directly in the epilepsy clinic.
Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be enrolled in the intervention.
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 purpose of this pre-piloting limited study is to streamline recruitment, intervention and outcome assessment process in preparation for a randomized, controlled pilot of the intervention.
Study Overview
Status
Withdrawn
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 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.
To test this idea, the study team seeks to pilot a feasibility trial of an epileptologist-driven medication treatment intervention for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP), using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity.
In this limited, intervention only pre-piloting trial, the team will streamline recruitment, intervention, and outcome assessment procedures to prepare for a randomized, controlled pilot of the intervention.
Study Type
Interventional
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
- Adequate cognition (MoCA score of 20 or greater)
- 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
- NDDI-E score greater than 15 and/or 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/theraptist
- 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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).
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Participants will be given escitalopram 10mg by mouth daily and will be followed up 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Intervention
Time Frame: 12 weeks
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accrual
Time Frame: 12 weeks
|
Percentage of patients screened for the trial who are eligible
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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 (ANTICIPATED)
May 1, 2018
Primary Completion (ANTICIPATED)
May 1, 2018
Study Completion (ANTICIPATED)
May 1, 2018
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (ACTUAL)
May 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
July 1, 2018
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
- IRB00048584-1st
- 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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