Ketamine in Adolescents With Treatment-Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Ketamine
Intervention description: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Treatment-resistant

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.
    

Eligibility 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.