Trial Outcomes & Findings for Lexapro for Major Depression in Patients With Epilepsy (NCT NCT01244724)

Results Overview

Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-07-11

Participant Flow

Of the 26 subjects enrolled only 17 actually returned and began medication.

Participant milestones

Participant milestones
Measure	Lexapro Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Overall Study STARTED	17
Overall Study Week 2 Visit	15
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lexapro for Major Depression in Patients With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lexapro n=15 Participants Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Age, Continuous	39.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Hamilton Depression Scale	25.5 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)

Outcome measures

Outcome measures
Measure	Lexapro n=15 Participants Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Hamilton Depression Scale	13.3 units on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: 12 Weeks

Population: Due to early termination of this study, data were not collected.

Seizure severity score for each seizure type.

Outcome measures

Outcome data not reported

Adverse Events

Lexapro

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lexapro n=15 participants at risk Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Nervous system disorders headache	26.7% 4/15 • Number of events 4 • Twelve weeks. Adverse events were identified though standardized questionnaire administered by the research team and reviewed by the Principal Investigator.

Additional Information

James H. Kocsis, M.D.

Weill Cornell Medical College

Phone: 212-746-5913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place