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Intranasal Ketamine in Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT01304147
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE February 23, 2011
First Posted Date  ICMJE February 25, 2011
Results First Submitted Date  ICMJE April 18, 2016
Results First Posted Date  ICMJE February 8, 2017
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: 2 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine in Treatment-Resistant Depression
Official Title  ICMJE Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    A single dose of intranasal ketamine up to 50 mg
  • Drug: placebo
    Single dose of saline intranasal
Study Arms  ICMJE
  • Experimental: Ketamine
    Subjects randomized to this arm will receive the active study medication, intranasal ketamine.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive intranasal saline.
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01304147
Other Study ID Numbers  ICMJE GCO 11-0492
INKET-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Murrough, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE James Murrough
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James W Murrough, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP