Intranasal Ketamine for Suicidal Ideation in Veterans

NCT03788694 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: GOO-17-048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Keywords

Ketamine; Veteran; Suicide; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks

• The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)

  Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks

Study Arms (1)

Intranasal Ketamine

EXPERIMENTAL

Subjects will receive study medication, intranasal ketamine.

Drug: Ketamine

Interventions

Ketamine DRUG

8 doses of intranasal ketamine; 40 mg per dose.

Intranasal Ketamine

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, 21-70 years of age
• 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
• Any non-psychotic disorder diagnosis
• 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
• 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
• Each participant must agree to avoid future enrollment in ketamine trials.

You may not qualify if:

• current psychotic symptoms or lifetime history of primary psychotic disorder
• active substance use in the preceding two weeks or needing medical attention for withdrawal
• neurodevelopmental disorder (e.g., ASD)
• major neurocognitive disorder (e.g., Alzheimer's type dementia)
• serious cardiac disease
• suicide attempt precipitating current admission requiring medical stabilization
• Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
• Women who are either pregnant or nursing
• Hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg) at screening or immediately prior to treatment with study drug
• Previously received ketamine for refractory depression.

Sponsors & Collaborators

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

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 27, 2018
• Study Start: January 1, 2020
• Primary Completion: January 31, 2020
• Study Completion: April 30, 2020
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication and will remain available for 5 years.

Locations

US (1)