CompletedPhase 4ketamine
Ketamine Infusion for Adolescent Depression and Anxiety
Sponsored by Yale University
NCT ID
NCT02579928
Target Enrollment
17 participants
Start Date
2015-10
Est. Completion
2019-09
About This Study
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).
Conditions Studied
Interventions
- •Ketamine
- •Midazolam
Eligibility
Age:13 Years - 17 Years
Healthy Volunteers:No
View full 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.
Study Locations (2)
Hospital Research Unit at the Yale New Haven Hospital
New Haven, Connecticut, United States
Yale Child Study Center
New Haven, Connecticut, United States