Intranasal Ketamine for Suicidal Ideation in Veterans

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03788694
• Other study ID #: GOO-17-048
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 1, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2023
• Source: Bronx Veterans Medical Research Foundation, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Drug:
• Ketamine
8 doses of intranasal ketamine; 40 mg per dose.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bronx Veterans Medical Research Foundation, Inc	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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