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

NCT01309581 | Terminated Results DMC

• 2 other identifiers: GCO 09-2251KETECT-MSSM-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

Conditions

Major Depression; Bipolar Depression

Keywords

depression; electroconvulsive therapy; ketamine; antidepressant

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression-24 (HRSD24)

  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.

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

Secondary Outcomes (1)

• Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)

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

Study Arms (2)

Ketamine

EXPERIMENTAL

Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Drug: Ketamine

Methohexital

ACTIVE COMPARATOR

Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Drug: Methohexital

Interventions

Ketamine DRUG

Ketamine 1-2 mg/kg IV as indicated for ECT

Ketamine

Methohexital DRUG

Methohexital 1 mg/kg IV as indicated for ECT

Methohexital

Eligibility Criteria

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

You may qualify if:

• Male or female patients: 18 to 59 years
• Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
• DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar
• Pretreatment 24-item Hamilton Rating Scale for Depression score \> 21
• ECT is clinically indicated
• Patient has the capacity to provide informed consent.

You may not qualify if:

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
• Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
• Current diagnosis of delirium, dementia, or amnestic disorder
• Baseline Mini Mental State Exam (MMSE) score \< 24 and a total score falling two standard deviations below the age- and education-adjusted mean
• Any active general medical condition or CNS disease which can affect cognition or response to treatment
• Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
• Lifetime history of ketamine or PCP abuse or dependence
• ECT within three months
• The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria
• Pregnancy

Sponsors & Collaborators

• James Murrough: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depression

Interventions

Ketamine; Methohexital

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination, limited enrollment, data analysis not done due to technical problems with measurement leading to unreliable and uninterpretable data.

Results Point of Contact

• Title: James Murrough
• Organization: Mount Sinai School of Medicine

James.Murrough@mssm.edu

212 241 7574

Study Officials

• James W Murrough, MD

  Icahn School of Medicine at Mount Sinai

  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
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 7, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-07

Locations

US (1)