Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anxiety and Depression in Epilepsy: A Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03464383
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Epilepsy Drug: Escitalopram 10mg Other: Referral to Psychiatry Other: Survey only Phase 4

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 why the population that do not meet criteria or refuse intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessment phone calls for gathering scaled instrument scores will be carried out by a second study coordinator, blinded to treatment assignment.
Primary Purpose: Treatment
Official Title: Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


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).
Drug: Escitalopram 10mg
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 Name: Lexapro

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.
Other: Referral to Psychiatry
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.

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.
Other: Survey only
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Accrual [ Time Frame: 12 weeks ]
    Percentage of patients screened for the trial who are eligible

  2. Retention [ Time Frame: 12 weeks ]
    Percentage of participants who complete the 12 week outcome assessment

  3. Efficacy - Change in Depression Symptoms [ Time Frame: 12 weeks ]
    12 weeks change in 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.

  4. Efficacy - Change in Anxiety Symptoms [ Time Frame: 12 weeks ]
    12 week change in 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464383


Locations
Layout table for location information
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Heidi Munger Clary, MD Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03464383     History of Changes
Other Study ID Numbers: IRB00048584
5UL1TR001420-03 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Neurologic Disorders
Chronic Care
Management
Treatment
SSRI Medication
SNRI Medication
Learning Healthcare System
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents