Intranasal Ketamine in Treatment-Resistant Depression

NCT ID: NCT01304147

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-10-31

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

A single dose of intranasal ketamine up to 50 mg

Placebo

Subjects randomized to this arm will receive intranasal saline.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Single dose of saline intranasal

Interventions

Ketamine

A single dose of intranasal ketamine up to 50 mg

Intervention Type: DRUG

placebo

Single dose of saline intranasal

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients, 21-65 years;

2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;

3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;

4. Current depressive episode;

5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;

6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;

7. 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;

8. 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

1. Women who plan to become pregnant, are pregnant or are breast-feeding;

2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;

3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;

4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;

5. Drug or alcohol abuse or dependence within the preceding 6 months;

6. Lifetime abuse or dependence on ketamine or phencyclidine;

7. Patients judged by study investigator to be at high risk for suicide.

8. Previous participation in a ketamine study at Mount Sinai

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Murrough

OTHER

Sponsor Role: lead

Responsible Party

James Murrough

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James W Murrough, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24821196 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34510411 (View on PubMed)

Other Identifiers

INKET-001

Identifier Type: -

Identifier Source: secondary_id

GCO 11-0492

Identifier Type: -

Identifier Source: org_study_id