Ketamine in the Treatment of Suicidal Depression
Condition: Major Depressive Disorder; Suicidal Ideation
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Suicidal Ideation
Intervention: Ketamine; Midazolam
Intervention description: Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes; Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ketamine; Midazolam; Major Depressive Disorder; Suicidal ideation; Suicide; Depression; Treatment; Ketamine Treatment

Summary:

      This study is designed to compare the effectiveness of two medications, Ketamine and
      Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.

      The first drug, Ketamine, is an experimental antidepressant that early studies have shown may
      quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the
      comparison drug, is not thought to reduce depression or suicidal thoughts.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Unipolar depression with current major depressive episode (MDE). Participants may be
             psychiatric medication-free, or if on psychiatric medication, not responding
             adequately given current MDE with suicidal ideation (See 2).

          -  Moderate to severe suicidal ideation

          -  18-65 years old

          -  Participants must agree to a voluntary admission to an inpatient research unit at the
             New York State Psychiatric Institute (NYSPI)for the infusion(s), for a brief stay, or
             longer if clinically necessary.

          -  Pre-menopausal female participants of child-bearing potential must be willing to use
             an acceptable form of birth control during study participation such as condoms,
             diaphragm, or oral contraceptive pills.

          -  Able to provide informed consent

          -  Participants 61-65 years old must score a 25 or higher on the Mini-Mental State
             Examination (MMSE) at screening.

        EXCLUSION CRITERIA:

          -  Unstable medical condition or neurological illness, including baseline hypertension
             (BP>140/90) or significant history of cardiovascular illness.

          -  Significant ECG abnormality

          -  Pregnant or lactating

          -  Diagnosis of bipolar disorder or psychotic disorder

          -  Contraindication to any study treatment.

          -  Inadequate understanding of English.

          -  Prior ineffective trial of or adverse reaction to Ketamine or Midazolam.

          -  Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3
             days pre-infusion.

          -  A diagnosis of sleep apnea.