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Intranasal Ketamine in Treatment-Resistant Depression

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ketamine

placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring ketamine, depression, treatment resistance, intranasal, antidepressant, glutamate, NMDA receptor

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, 21-65 years;
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
Primary diagnosis of major depressive disorder as assessed by the SCID-P;
Current depressive episode;
History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

Women who plan to become pregnant, are pregnant or are breast-feeding;
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
Drug or alcohol abuse or dependence within the preceding 6 months;
Lifetime abuse or dependence on ketamine or phencyclidine;
Patients judged by study investigator to be at high risk for suicide.
Previous participation in a ketamine study at Mount Sinai

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

Subjects randomized to this arm will receive the active study medication, intranasal ketamine.

Subjects randomized to this arm will receive intranasal saline.

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)

Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.

Secondary Outcome Measures

Systematic Assessment for Treatment Emergent Effects (SAFTEE)

This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.

Full Information

NCT ID

NCT01304147

First Posted

February 23, 2011

Last Updated

December 16, 2016

Sponsor

James Murrough

1. Study Identification

Unique Protocol Identification Number

NCT01304147

Brief Title

Intranasal Ketamine in Treatment-Resistant Depression

Official Title

Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James Murrough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

ketamine, depression, treatment resistance, intranasal, antidepressant, glutamate, NMDA receptor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Subjects randomized to this arm will receive the active study medication, intranasal ketamine.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects randomized to this arm will receive intranasal saline.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

A single dose of intranasal ketamine up to 50 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Single dose of saline intranasal

Primary Outcome Measure Information:

Title

Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Systematic Assessment for Treatment Emergent Effects (SAFTEE)

Description

This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, 21-65 years; Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study; Primary diagnosis of major depressive disorder as assessed by the SCID-P; Current depressive episode; History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode; Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2; Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document; Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact. Exclusion Criteria: Women who plan to become pregnant, are pregnant or are breast-feeding; Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease; Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG; Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome; Drug or alcohol abuse or dependence within the preceding 6 months; Lifetime abuse or dependence on ketamine or phencyclidine; Patients judged by study investigator to be at high risk for suicide. Previous participation in a ketamine study at Mount Sinai

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W Murrough, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York City

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24821196

Citation

Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1016/j.biopsych.2014.03.026. Epub 2014 Apr 3.

Results Reference

result

PubMed Identifier

34510411

Citation

Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

Results Reference

derived

Links:

URL

http://www.mssm.edu/research/programs/mood-and-anxiety-disorders-program

Description

Mount Sinai School of Medicine Mood and Anxiety Disorders Program

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Intranasal Ketamine in Treatment-Resistant Depression

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