Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2020-01-01
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intranasal Ketamine
Subjects will receive study medication, intranasal ketamine.
Ketamine
8 doses of intranasal ketamine; 40 mg per dose.
Interventions
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Ketamine
8 doses of intranasal ketamine; 40 mg per dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
70 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Bronx Veterans Medical Research Foundation, Inc
OTHER
Responsible Party
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Marianne Goodman
Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program
Locations
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James J. Peters VA Medical Center
The Bronx, New York, United States
Countries
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Other Identifiers
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GOO-17-048
Identifier Type: -
Identifier Source: org_study_id
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