Trial Outcomes & Findings for Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression (NCT NCT01309581)

Results Overview

The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the "gold standard" clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Change from beginning of ECT treatment to end; on average 3 weeks

Results posted on

2013-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).	Methohexital Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=2 Participants Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).	Methohexital n=1 Participants Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).	Total n=3 Participants Total of all reporting groups
Age Continuous	53 years STANDARD_DEVIATION 5.6 • n=5 Participants	50 years STANDARD_DEVIATION 0 • n=7 Participants	50 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from beginning of ECT treatment to end; on average 3 weeks

The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the "gold standard" clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from beginning of ECT treatment to end; on average 3 weeks

The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).

Outcome measures

Outcome data not reported

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Methohexitol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=2 participants at risk	Methohexitol n=1 participants at risk
Nervous system disorders Headache	50.0% 1/2 • Number of events 1	0.00% 0/1
Renal and urinary disorders Frequent Urination	50.0% 1/2 • Number of events 1	0.00% 0/1
Gastrointestinal disorders Constipation	0.00% 0/2	100.0% 1/1 • Number of events 1
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1	0.00% 0/1
Cardiac disorders Dizziness on standing	50.0% 1/2 • Number of events 1	0.00% 0/1
Nervous system disorders Sleep disturbance	50.0% 1/2 • Number of events 1	0.00% 0/1
Nervous system disorders Restlessness	0.00% 0/2	100.0% 1/1 • Number of events 1

Additional Information

James Murrough

Mount Sinai School of Medicine

Phone: 212 241 7574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place