Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Ketamine Infusion for Adolescent Depression and Anxiety

Randomised, quadruple-blind, crossover adolescent trial (n=17 actual) assessing single IV ketamine (0.5 mg/kg) versus active midazolam (0.045 mg/kg) for medication-refractory MDD or anxiety disorders with 2-week washout.

Target Enrollment
17 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, crossover trial in adolescents with medication-refractory major depressive disorder or anxiety disorders (actual N=17). Participants received a single IV infusion of ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) with a 2-week washout between sessions.

Primary outcomes are change in MADRS score (MDD cohort) and change in MASC acute physical symptoms subscale (anxiety cohort) at 1 day post-infusion; safety/tolerability monitored during infusion and for hours afterwards.

Study Protocol

Preparation

sessions

Dosing

2 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine 0.5 mg/kg; crossover with midazolam; 2-week washout.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    IV infusion over 40 minutes; max total dose 50 mg; monitored hourly for 3 h post-infusion.

Midazolam

active comparator

Single IV midazolam 0.045 mg/kg as active comparator.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    IV infusion over 40 minutes; max total dose 4.5 mg; active control (Versed).

Participants

Ages
13 – 17
Sexes
Male & Female

Inclusion Criteria

  • Inclusion:
  • MDD Cohort:
  • Meet DSM-5 criteria for Major Depressive Disorder by structured interview (MINI-KID)
  • CDRS-R score >40.
  • Failure to achieve remission with at least 1 adequate prior antidepressant trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.
  • Anxiety Cohort:
  • Meet DSM-5 criteria for any of the following anxiety disorders: Social Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder and/or Panic Disorder by structured interview (MINI-KID)
  • ADIS Clinical Severity Rating ≥4 (moderately severe) for any of the 4 included anxiety disorders
  • Failure to achieve remission with at least 1 adequate prior anxiolytic medication trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.
  • Failure to achieve remission with previous CBT or subject declines current CBT therapy
  • Both cohorts:
  • Stable psychiatric medications and doses for the month prior to enrollment. Subjects may continue to engage in any ongoing psychotherapy.
  • Medically and neurologically healthy on the basis of physical examination and medical history.
  • Parents able to provide written informed consent and adolescents must additionally provide assent.

Exclusion Criteria

  • Exclusion:
  • Current inpatient hospitalization or active suicidal ideation requiring referral for inpatient hospitalization for safety.
  • History of psychotic disorder or manic episode diagnosed by MINI-KID
  • History of substance dependence diagnosis by MINI-KID (excluding tobacco) or positive urine toxicology.
  • Pregnancy (urine pregnancy tests on the day of scans for menstruating girls).
  • Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.

Study Details

Study Team

Sponsors & Collaborators

Locations

Hospital Research Unit at the Yale New Haven Hospital — New Haven, Connecticut, United States
Yale Child Study Center — New Haven, Connecticut, United States

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