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Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295787
Recruitment Status : Withdrawn (No funding)
First Posted : November 20, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dawn F Ionescu, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE November 20, 2014
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: Up to 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine for Late-Life Depression and Suicidal Ideation
Official Title  ICMJE Intranasal Ketamine for Late-Life Depression and Suicidal Ideation
Brief Summary The investigators of this study plan to investigate the feasibility and efficacy of repeated doses of intranasal ketamine in severely depressed patients who are at least 65 years of age and experiencing suicidal ideation. The results of the study could lead to development of new strategies for treating depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicide
  • Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine
    Intranasal ketamine for late-life depression and suicidal ideation.
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Intranasal Ketamine 50mg administered six times over three weeks.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Intranasal saline solution administered six times over three weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 22, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2014)
30
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1) be ≥65 years old, 2) provide written informed consent, 3) meet criteria for a primary psychiatric diagnosis of major depressive disorder according to the Structured Clinical Interview for DSM-IV (SCID) and have a HDRS28 total score ≥20; depression may have started at any time point in their life, and certain co-morbid diagnoses (e.g., anxiety disorders) will be allowed insofar as they are not the primary psychiatric diagnosis, 4) have a history of ≥2 failed medication trials during the current episode (per the Massachusetts General Hospital Antidepressant Treatment History Questionnaire; MGH ATRQ), 5) endorse suicidal ideation for more than 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS) and have a HDRS28 suicide item score ≥1 (thoughts that life isn't worth living), 6) be on a stable antidepressant regimen for ≥14 days prior to Study Phase II, 7) maintain a treating psychiatrist who is in agreement with study participation, and 8) have a reliable chaperone accompany them home following the completion of the intranasal administration.

Exclusion Criteria:

  • Patients will be excluded if any of the following criteria are met: 1) Delirium or dementia diagnosis, 2) unstable medical illness, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects, 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders or homicidality, 6) active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine abuse, 7) requirement of excluded medications (narcotics, barbiturates, theophylline, or St. John's Wort), or 8) concurrent or recent participation in other research studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295787
Other Study ID Numbers  ICMJE 2014D006212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dawn F Ionescu, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn F Ionescu, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2017

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