CompletedPhase 3ketamine

Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

Sponsored by The University of Texas Health Science Center, Houston

NCT ID
NCT03539887
Target Enrollment
33 participants
Start Date
2018-05-01
Est. Completion
2022-01-15

About This Study

This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.

Conditions Studied

Suicidal IdeationDepressionAlcohol Abuse

Interventions

  • Intranasal ketamine
  • Placebo

Eligibility

Age:21 Years - 60 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Voluntary admission to Harris County Psychiatry Center
* Able to provide written informed consent
* Current suicidal ideation and depressive symptoms and Diagnostic and Statistical Manual of Mental Disorders -IV- Text Revision(DSM-IV-TR) depressive episode (also MADRS greater than or equal to 12) and Young Mania Rating Scale (YMRS) score lower than 8
* DSM-IV-TR criteria for current alcohol abuse (but not intoxicated/withdrawal, abstinent from drinking for \> 5 days prior to admission).
* Lifetime history of suicide attempt (patient)
* Not taking any medication in the last 24hs.
* Scale for Suicide Ideation (SSI) score over 4 (first five items) and Columbia scale (C-SSRS) score 4 or 5

Exclusion Criteria:

* Unstable medical condition or medical problem with known central nervous system (CNS) effects, e.g. uncontrolled hypertension systolic blood pressure (SBP) ≥170 and/or diastolic blood pressure (DBP) ≥100) or recent history (6 months) of alcohol-withdrawal seizures or significant abnormal laboratory tests (liver function test (LFT) 3 times higher than normal).
* Prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, psychotic symptoms, or personality disorder.
* Currently under the acute effects of an illicit substance.
* Pregnant or nursing women.
* Subjects with a history of DSM-IV drug dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months

Study Locations (1)

The University of Texas Health Science Center at Houston
Houston, Texas, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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