Intranasal Ketamine for Suicidal Ideation in Veterans

Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans

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.

Study Overview

• Status: Withdrawn
• Conditions: Suicidal Ideation
• Intervention / Treatment: Drug: Ketamine

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 Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rachel Harris, MA; Phone Number: 3718 718-584-9000; Email: Rachel.Harris6@va.gov
• Study Contact Backup: Name: Marianne Goodman, MD; Phone Number: 5188 718-584-9000; Email: Marianne.Goodman@va.gov

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Scale for Suicidal Ideation (BSSI)	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.	Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	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.	Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)	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.	Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks

Collaborators and Investigators

• Sponsor: Bronx Veterans Medical Research Foundation, Inc
• Collaborators: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ketamine; Suicide; Veteran; Suicidal Ideation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; 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: GOO-17-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.
• IPD Sharing Time Frame: 6 months after publication and will remain available for 5 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No