Trial Outcomes & Findings for Anxiety and Depression in Epilepsy: A Treatment Study (NCT NCT03464383)
NCT ID: NCT03464383
Last Updated: 2020-10-19
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
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 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).
|
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.
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
63
|
|
Overall Study
COMPLETED
|
2
|
2
|
63
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
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 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).
|
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.
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.
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Epileptologist-Driven Treatment
n=3 Participants
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 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).
|
Standard of Care
n=3 Participants
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.
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
n=63 Participants
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.
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.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
61 Participants
n=63 Participants
|
67 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=63 Participants
|
2 Participants
n=69 Participants
|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 6.1 • n=3 Participants
|
41.3 years
STANDARD_DEVIATION 4.0 • n=3 Participants
|
42.2 years
STANDARD_DEVIATION 13.5 • n=63 Participants
|
42.0 years
STANDARD_DEVIATION 13.0 • n=69 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
40 Participants
n=63 Participants
|
42 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
23 Participants
n=63 Participants
|
27 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=63 Participants
|
4 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
47 Participants
n=63 Participants
|
53 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=63 Participants
|
12 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
9 Participants
n=63 Participants
|
10 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
48 Participants
n=63 Participants
|
53 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=63 Participants
|
4 Participants
n=69 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
63 participants
n=63 Participants
|
69 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome only pertains to the experimental arm. This was an intention-to treat analysis including all who were randomized to the 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)
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=3 Participants
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 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).
|
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.
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.
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.
|
|---|---|---|---|
|
Adherence to Intervention
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Number of participants analyzed were not all consented or randomized. These were pre-screening numbers.
Percentage of patients screened for the trial who are eligible
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=681 Participants
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 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).
|
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.
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.
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.
|
|---|---|---|---|
|
Accrual
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: This is the number who were pre-screened and who were eligible to consent.
Percent eligible who consent to participate in treatment study
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=19 Participants
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 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).
|
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.
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.
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.
|
|---|---|---|---|
|
Participants Eligible for Consent Into Treatment Arms
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This was an intention-to treat analysis including all who were randomized to the intervention.
Percentage of participants who complete the 12 week outcome assessment
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=3 Participants
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 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).
|
Standard of Care
n=3 Participants
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.
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.
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.
|
|---|---|---|---|
|
Retention
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.
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.
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=3 Participants
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 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).
|
Standard of Care
n=3 Participants
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.
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.
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.
|
|---|---|---|---|
|
Efficacy - Depression Symptoms
|
26.7 score on a scale
Standard Deviation 3.5
|
21.0 score on a scale
Standard Deviation 7.2
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.
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.
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=2 Participants
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 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).
|
Standard of Care
n=2 Participants
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.
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.
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.
|
|---|---|---|---|
|
Efficacy - Depression Symptoms
|
25.0 score on a scale
Standard Deviation 5.7
|
17.0 score on a scale
Standard Deviation 8.5
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: This outcome does not apply to survey arm. Baseline measurements were done before subjects in each treatment arm were lost to follow up and withdrew consent.
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.
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=3 Participants
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 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).
|
Standard of Care
n=3 Participants
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.
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.
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.
|
|---|---|---|---|
|
Efficacy - Anxiety Symptoms
|
18.0 score on a scale
Standard Deviation 9.6
|
10.5 score on a scale
Standard Deviation 2.1
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This outcome does not apply to survey arm. 12 week measurements were done after subjects in each treatment arm were lost to follow up and withdrew consent.
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.
Outcome measures
| Measure |
Epileptologist-Driven Treatment
n=2 Participants
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 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).
|
Standard of Care
n=1 Participants
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.
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.
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.
|
|---|---|---|---|
|
Efficacy - Anxiety Symptoms
|
9.5 score on a scale
Standard Deviation 9.2
|
11 score on a scale
|
—
|
Adverse Events
Epileptologist-Driven Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Survey Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Epileptologist-Driven Treatment
n=3 participants at risk
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 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).
|
Standard of Care
n=3 participants at risk
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.
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
n=63 participants at risk
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.
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.
|
|---|---|---|---|
|
Nervous system disorders
sudden unexpected death in epilepsy
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
1.6%
1/63 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
Other adverse events
| Measure |
Epileptologist-Driven Treatment
n=3 participants at risk
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 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).
|
Standard of Care
n=3 participants at risk
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.
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
n=63 participants at risk
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.
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
tooth pain from impacted wisdom tooth
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
|
Reproductive system and breast disorders
sexual dysfunction
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
|
Nervous system disorders
tremor
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
|
Endocrine disorders
night sweats
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
|
Nervous system disorders
headache
|
0.00%
0/3 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
33.3%
1/3 • Number of events 1 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
0.00%
0/63 • Baseline through 12 weeks for experimental and standard of care arms. For survey arm, from survey completion to time when incentive gift card communications were completed.
|
Additional Information
Heidi M. Munger Clary, MD, MPH Associate Professor of Neurology
Wake Forest University School of Medicine
Phone: 336-716-7110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place