Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

Intranasal Ketamine in Treatment-Resistant Depression

Randomised, quadruple-blind, crossover study (n=20) comparing a single intranasal ketamine dose (up to 50 mg) versus intranasal saline in treatment-resistant depression.

Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind crossover in 20 participants with treatment-resistant major depressive disorder comparing a single intranasal ketamine dose (up to 50 mg) with intranasal saline.

Primary purpose to evaluate safety and efficacy; eligibility required IDS-C30 thresholds and prior inadequate response to at least one antidepressant. Safety assessed via labs, ECG, and adverse events.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Active intranasal ketamine arm; single-dose crossover.

Interventions

  • Ketamine50 mg
    via Other• single dose• 1 doses total

    Intranasal administration up to 50 mg.

Placebo

inactive

Intranasal saline placebo comparator; single-dose crossover.

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Intranasal saline.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Male or female patients, 21-65 years;
  • Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
  • Primary diagnosis of major depressive disorder as assessed by the SCID-P;
  • Current depressive episode;
  • History of failure to respond to at least one adequate pharmacotherapy trial in the current major depressive episode;
  • Subjects must have scored ≥30 on the IDS-C30 at Screening and ≥24 at Treatment Day #1 and #2;
  • Capacity to provide informed consent;
  • Must identify a family member, physician, or friend to participate in the Treatment Contract and serve as emergency contact.

Exclusion Criteria

  • Women who plan to become pregnant, are pregnant or are breast-feeding;
  • Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
  • Clinically significant abnormal laboratory parameters, physical exam, or ECG;
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, intellectual disability, pervasive developmental disorders, or Tourette's syndrome;
  • Drug or alcohol abuse or dependence within the preceding 6 months;
  • Lifetime abuse or dependence on ketamine or phencyclidine;
  • Patients judged by study investigator to be at high risk for suicide;
  • Previous participation in a ketamine study at Mount Sinai.

Study Details

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

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