Anxiety and Depression in Epilepsy: A Pilot Treatment Study

Depression Clinical Trial

Official title:

Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03522987
• Other study ID #: IRB00048584-1st
• Secondary ID: 5UL1TR001420-03
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2018
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Epilepsy

Intervention

Drug:
• Escitalopram 10mg
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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accrual	Percentage of patients screened for the trial who are eligible	12 weeks