Overview

Ketamine in Adolescents With Treatment-Resistant Depression

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
This study will test the use of ketamine for treatment of depression in adolescents that have not responded to other treatments. We will also examine neurobiological mechanisms of treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Treatments:
Ketamine
Criteria
Inclusion Criteria:

- Male and female adolescents aged 12 to 18 years.

- Presence of recurrent major depression without psychotic features confirmed by the
Kiddie-Schedule for Affective Disorders and Schizophrenia - Parent and Lifetime
Version (Kaufman et al., 1997).

- Current depression severity measured by the Children's Depression Rating Scale (CDRS)
(Poznanski, 1985) raw score greater than or equal to 36 at screening and the day
ketamine is due to be received for the first time.

- Current depressive episode resistant to treatment, defined as failure to achieve
remission (elimination of symptoms and restoration of pre-morbid psychosocial
functioning) from at least 2 antidepressant trials of different pharmacological
classes. Systematic evaluation of previous antidepressant trials will be assessed by
using the Antidepressant Treatment History Form (Sackeim, 2001).

- If present, current antidepressant medication treatment must be dose stable for at
least 2 months prior to beginning the study. (Patients will continue with current
antidepressant treatment throughout the study. Based on our experience in current
research at the VA Medical Center using serial ketamine for adult TRD, patients have
shown positive results while continuing their current antidepressant treatment.)

Exclusion Criteria:

- Inability to speak English

- Inability or unwillingness to provide written informed consent

- A history of Mental Retardation or any Pervasive Developmental Disorder

- Current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis
Not Otherwise Specified.

- Family history with a first degree relative with schizophrenia, schizoaffective
disorder, or psychosis Not Otherwise Specified.

- Diagnosis of seizures or other neurological disorders.

- Comorbid diagnosis of substance abuse or dependence, current or past.

- Clinically unstable medical illness.

- Current use of the following medications: any barbiturates, any narcotics, any
non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for
insomnia.

- For women: pregnancy (confirmed by baseline lab test).

- The presence of any MRI contra-indications such as MRI-incompatible metals in the body
or claustrophobia.