Intranasal Ketamine in Treatment-Resistant Depression

NCT01304147 | Completed Results DMC

• 2 other identifiers: GCO 11-0492INKET-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (1)

• Systematic Assessment for Treatment Emergent Effects (SAFTEE)

  2 weeks

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive intranasal saline.

Drug: placebo

Interventions

Ketamine DRUG

A single dose of intranasal ketamine up to 50 mg

Ketamine

placebo DRUG

Single dose of saline intranasal

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• James Murrough: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 24821196 RESULT

• 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.

  PMID: 34510411 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Small sample size. Ongoing treatment with psychotropic medication allowed at stable doses makes it difficult to distinguish an intrinsic effect of ketamine from benefits resulting from the combination of ketamine with other antidepressant agents.

Results Point of Contact

• Title: Dr. James W. Murrough
• Organization: Icahn School of Medicine at Mount Sinai

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 25, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Locations

US (1)