Trial Outcomes & Findings for Focal Electroconvulsive Therapy for Depression (NCT NCT01589315)

Results Overview

The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed. The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of \< or equal to 10.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

17 participants

Primary outcome timeframe

up to 4 weeks

Results posted on

2019-08-20

Participant Flow

We planned to enroll up to 20 but only enrolled 17 due to time and budget issues.

Participant milestones

Participant milestones
Measure	FEAST Active right unilateral focal ECT focal ECT: FEAST, ECT, unidirectional stimulation
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Focal Electroconvulsive Therapy for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FEAST n=17 Participants Active right unilateral focal ECT focal ECT: FEAST, ECT, unidirectional stimulation
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	53 years STANDARD_DEVIATION 2 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Baseline HRSD24	33 units on a scale STANDARD_DEVIATION 6.8 • n=99 Participants

PRIMARY outcome

Timeframe: up to 4 weeks

The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed. The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of \< or equal to 10.

Outcome measures

Outcome measures
Measure	FEAST n=17 Participants Active right unilateral focal ECT focal ECT: FEAST, ECT, unidirectional stimulation
Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item.	5 Participants

Adverse Events

FEAST

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FEAST n=17 participants at risk Active right unilateral focal ECT focal ECT: FEAST, ECT, unidirectional stimulation
Skin and subcutaneous tissue disorders first degree burn at electrode	11.8% 2/17 • Number of events 2

Additional Information

Mark S. George, MD

Medical University of South Carolina

Phone: 1843876 5142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place