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Phase 4 N=17 Randomized Quadruple-blind Treatment

Ketamine Infusion for Adolescent Depression and Anxiety

Major Depressive Disorder · Anxiety Disorder

Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion — 15.44; 24.13 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ketamine (Drug); Midazolam (Drug)
Age
Pediatric · 13+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion
15.44; 24.13

Summary

The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).

Eligibility 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 Disorders, 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:

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02579928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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