Ketamine Infusion for Adolescent Depression and Anxiety

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: American Academy of Child Adolescent Psychiatry.
• Treatments: Ketamine; Midazolam

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.