Intranasal Ketamine in Treatment-Resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01304147
First received: February 23, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Major Depressive Disorder
Drug: Ketamine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304147

Contacts
Contact: Cara Levitch 212-241-3116 cara.levitch@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York City, New York, United States, 10029
Contact: Cara Levitch    212-241-3116    cara.levitch@mssm.edu   
Principal Investigator: James W Murrough, MD         
Sub-Investigator: Kyle Lapidus, MD, PhD         
Sub-Investigator: Dan Iosifescu, MD         
Sub-Investigator: Laili Someilani, MD         
Sub-Investigator: Andrew Perez, MD         
Sub-Investigator: LeBen Wan, MD         
Sponsors and Collaborators
James Murrough
Investigators
Principal Investigator: James W Murrough, MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: James Murrough, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01304147     History of Changes
Other Study ID Numbers: GCO 11-0492, INKET-001
Study First Received: February 23, 2011
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
ketamine
depression
treatment resistance
intranasal, antidepressant
glutamate
NMDA receptor

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014