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General Anesthetic

Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression

Phase 4

Waitlist Available

Led By Ian McIntyre, MD, MSc

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately one week prior to, and at 2, 4 and 8 weeks post ect

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of depressive symptoms with and without pre-emptive hyperventilation will also be studied.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately one week prior to, and at 2, 4 and 8 weeks post ect

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately one week prior to, and at 2, 4 and 8 weeks post ect

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately one week prior to, and at 2, 4 and 8 weeks post ect for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ECT-induced seizure duration (seconds)

Electroencephalography

Secondary study objectives

Changes in cerebral metabolism assessed by cerebral saturation (%)

Effect on blood pressure

Effect on heart rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Active Control

Group I: ECT with EtomidateActive Control2 Interventions

Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose.

Group II: ECT with KetamineActive Control2 Interventions

Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose.

Group III: ECT with Etomidate and HyperventilationActive Control3 Interventions

Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.

Group IV: ECT with Ketamine and HyperventilationActive Control3 Interventions

Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.

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