Phase 4
N=17
Ketamine Infusion for Adolescent Depression and Anxiety
Major Depressive Disorder · Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02579928 ↗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
| Outcome | Result | p-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.
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.