Trial Outcomes & Findings for Ketamine Anesthesia in Electroconvulsive Therapy (NCT NCT01367119)

Results Overview

The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline and after every second treatment for 7 treatments

Results posted on

2013-08-08

Participant Flow

Subjects were enrolled at Mayo Clinic, Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Ketamine Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Overall Study STARTED	21	17
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Ketamine Anesthesia in Electroconvulsive Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=21 Participants Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital n=17 Participants Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.	Total n=38 Participants Total of all reporting groups
Age Continuous	46.95 years STANDARD_DEVIATION 13.17 • n=5 Participants	48.65 years STANDARD_DEVIATION 7.20 • n=7 Participants	47.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	17 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after every second treatment for 7 treatments

Population: Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.

The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.

Outcome measures

Outcome measures
Measure	Ketamine n=21 Participants Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital n=17 Participants Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)	22.08 units on a scale Standard Deviation 8.11	24.45 units on a scale Standard Deviation 7.70

SECONDARY outcome

Timeframe: Baseline and after every second treatment for 7 treatments

Population: Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.

The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.

Outcome measures

Outcome measures
Measure	Ketamine n=21 Participants Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital n=17 Participants Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)	15.98 units on a scale Standard Deviation 7.54	17.57 units on a scale Standard Deviation 6.96

SECONDARY outcome

Timeframe: Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure

Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) - absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.

Outcome measures

Outcome measures
Measure	Ketamine n=21 Participants Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).	Methohexital n=17 Participants Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Mean Post Anesthesia Recovery Side Effects Nausea	0.12 units on a scale Standard Deviation 0.39	0.15 units on a scale Standard Deviation 0.42
Mean Post Anesthesia Recovery Side Effects Headache	0.29 units on a scale Standard Deviation 0.61	0.35 units on a scale Standard Deviation 0.67
Mean Post Anesthesia Recovery Side Effects Myalgia	0.07 units on a scale Standard Deviation 0.30	0.15 units on a scale Standard Deviation 0.48
Mean Post Anesthesia Recovery Side Effects Visual Disturbance	0.08 units on a scale Standard Deviation 0.28	0.01 units on a scale Standard Deviation 0.11
Mean Post Anesthesia Recovery Side Effects Confusion	0.70 units on a scale Standard Deviation 0.95	0.30 units on a scale Standard Deviation 0.53
Mean Post Anesthesia Recovery Side Effects Recovery Room Agitation	0.07 units on a scale Standard Deviation 0.26	0.09 units on a scale Standard Deviation 0.36

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Methohexital

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Keith G. Rassmussen

Mayo Clinic

Phone: 507-284-2933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place