Anxiety and Depression in Epilepsy: A Treatment Study

NCT03464383 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB000485845UL1TR001420-03
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depression; Epilepsy

Keywords

Neurologic Disorders; Chronic Care; Management; Treatment; SSRI Medication; SNRI Medication; Learning Healthcare System

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (7)

• Accrual

  baseline

• Participants Eligible for Consent Into Treatment Arms

  baseline

• Retention

  12 weeks

• Efficacy - Depression Symptoms

  baseline

• Efficacy - Depression Symptoms

  12 weeks

Study Arms (3)

Epileptologist-Driven Treatment

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Survey Arm

OTHER

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

Interventions

Escitalopram 10mg DRUG

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

Epileptologist-Driven Treatment

Referral to Psychiatry OTHER

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.

Standard of Care

Survey only OTHER

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.

Survey Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Epilepsy; Nervous System Diseases

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Heidi M. Munger Clary, MD, MPH Associate Professor of Neurology
• Organization: Wake Forest University School of Medicine

hmungerc@wakehealth.edu

336-716-7110

Study Officials

• Heidi Munger Clary, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment phone calls for gathering scaled instrument scores will be carried out by a second study coordinator, blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two groups. Those randomized to the intervention group will receive an epileptologist-driven medication treatment for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP). Those randomized to the control group will receive an referral order to psychiatry placed by their epileptologist.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: May 7, 2018
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)