Ketamine Anesthesia in Electroconvulsive Therapy

NCT01367119 | Completed Results

• 1 other identifier: 11-001430
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT) accelerate the antidepressant effect of ECT? The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.

Conditions

Depression

Keywords

Depression; Electroconvulsive therapy; Ketamine; Methohexital

Outcome Measures

Primary Outcomes (1)

• Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)

  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.

  Baseline and after every second treatment for 7 treatments

Secondary Outcomes (2)

• Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)

  Baseline and after every second treatment for 7 treatments

• Mean Post Anesthesia Recovery Side Effects

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

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).

Drug: Ketamine

Methohexital

ACTIVE COMPARATOR

Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.

Drug: methohexital

Interventions

Ketamine DRUG

Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.

Also known as: Ketalar, Ketamine Hydrocholoride

Ketamine

methohexital DRUG

Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.

Also known as: Brevital Sodium

Methohexital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of depression, either unipolar or bipolar
• Subjects receiving ECT at the Mayo Clinic

You may not qualify if:

• Subjects not giving their own consent to ECT
• Subjects with schizophrenia, schizoaffective disorder, or dementia
• Subjects diagnosed with a major neurological disorder such as epilepsy, Parkinson disease, multiple sclerosis, or a neurodegenerative dementia.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine; Methohexital

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Keith G. Rassmussen
• Organization: Mayo Clinic

rasmussen.keith@mayo.edu

507-284-2933

Study Officials

• Keith Rasmussen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 6, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 8, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-08

Locations

US (1)