Houston, Texas 77006

  • Alcohol Abuse

Purpose:

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.


Study summary:

Clinicians have a limited ability to predict imminent suicidal behavior and efficacious treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for suicidal individuals are truly needed. 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. These results will elucidate the antisuicidal effects of ketamine using the intranasal route along with the identification of associated mediators or moderators; this approach has the potential for enormous public health impact.


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. - 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


NCT ID:

NCT03539887


Primary Contact:

Principal Investigator
Rodrigo Machado-Vieira, MD, PhD, MSc
The University of Texas Health Science Center, Houston

Rodrigo Machado-Vieira, MD, PhD, MSc
Phone: (713) 741-5000
Email: Rodrigo.MachadoVieira@uth.tmc.edu


Backup Contact:

Email: Courtney.Vecera@uth.tmc.edu
Courtney Vecera
Phone: (713) 741-6043


Location Contact:

Houston, Texas 77006
United States

Rodrigo Machado-Vieira, MD PhD MSc(713) 741-3830
Phone: (713) 741-3830
Email: Rodrigo.MachadoVieira@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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