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CompletedPhase 4Results posted

Ketamine Infusion for Adolescent Depression and Anxiety

NCT02579928 · Yale University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
17
Target enrolment
2
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion

    Measured over 1 day after the infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

13 Years to 17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

2 study sites

FacilityCityRegionCountry
Hospital Research Unit at the Yale New Haven HospitalNew HavenConnecticutUnited States
Yale Child Study CenterNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT02579928 on ClinicalTrials.gov →

Last updated in the registry 2020-07-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits