Clinical trial NCT03788694: Intranasal Ketamine for Suicidal Ideation in Veterans
Official title: Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Suicidal Ideation
Keywords: Ketamine
Veteran
Suicide
Suicidal Ideation
Lead sponsor: Bronx Veterans Medical Research Foundation, Inc
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2018-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Beck Scale for Suicidal Ideation (BSSI)
timeFrame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
measure: The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)
timeFrame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
References: