Intranasal Ketamine in Treatment-Resistant Depression

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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Ketamine; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York City, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ketamine; Subjects randomized to this arm will receive the active study medication, intranasal ketamine.	Drug: Ketamine; A single dose of intranasal ketamine up to 50 mg
PLACEBO_COMPARATOR: Placebo; Subjects randomized to this arm will receive intranasal saline.	Drug: placebo; Single dose of saline intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Collaborators and Investigators

• Sponsor: James Murrough

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Mount Sinai School of Medicine Mood and Anxiety Disorders Program

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (ESTIMATE): February 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2017
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: depression; ketamine; NMDA receptor; glutamate; treatment resistance; intranasal, antidepressant
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: GCO 11-0492; INKET-001