Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Ketamine for Suicidal Ideation in Veterans

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788694
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Marianne Goodman, James J. Peters Veterans Affairs Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Drug: Ketamine Early Phase 1

Detailed Description:
To address the significant need for effective treatment of suicidal ideation in Veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intranasal Ketamine
Subjects will receive study medication, intranasal ketamine.
 Drug: Ketamine
8 doses of intranasal ketamine; 40 mg per dose.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]
    Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]
    The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

  2. The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]
    QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients, 21-70 years of age
  2. Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration
  3. Any non-psychotic disorder diagnosis
  4. Score >4 on the suicide item of the Montgomery-Asberg Depression Rating Scale (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide attempts
  5. Each participant 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
  6. Each participant must agree to avoid future enrollment in ketamine trials.

Exclusion Criteria:

  1. current psychotic symptoms or lifetime history of primary psychotic disorder
  2. active substance use in the preceding two weeks or needing medical attention for withdrawal
  3. neurodevelopmental disorder (e.g., ASD)
  4. major neurocognitive disorder (e.g., Alzheimer's type dementia)
  5. serious cardiac disease
  6. suicide attempt precipitating current admission requiring medical stabilization
  7. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
  8. Women who are either pregnant or nursing
  9. Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with study drug
  10. Previously received ketamine for refractory depression.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788694


Contacts
Layout table for location contacts
Contact: Rachel Harris, MA 718-584-9000 ext 3718 Rachel.Harris6@va.gov
Contact: Marianne Goodman, MD 718-584-9000 ext 5188 Marianne.Goodman@va.gov

Locations
Layout table for location information
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Rachel Harris, MA    718-584-9000 ext 3718    Rachel.Harris6@va.gov   
Contact: Rene Kahn, MD    718-584-9000 ext 5225    rene.kahn@mssm.edu   
Principal Investigator: Marianne Goodman, MD         
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
Icahn School of Medicine at Mount Sinai
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Marianne Goodman, Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03788694    
Other Study ID Numbers: GOO-17-048
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months after publication and will remain available for 5 years.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marianne Goodman, James J. Peters Veterans Affairs Medical Center:
Ketamine
Veteran
Suicide
Suicidal Ideation
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action