Clinical TrialSingle-armKetamineCompleted

IV Ketamine for Adolescents with Treatment-Resistant Depression: Open-Label Pilot (Cullen 2018, University of Minnesota)

Single-arm open-label Phase 2 pilot listed on ClinicalTrials.gov (NCT02078817). Participants: adolescents aged 12-18 with MDD and TRD. Intervention: six IV ketamine infusions at 0.5 mg/kg over 40 minutes over 2 weeks. The published paper defines percent change in CDRS-R from baseline to 1 day after the final infusion as the primary outcome; CTG lists CGI responder count at 2 weeks as the registered primary outcome.

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Target Enrollment
13 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine

experimental

Six serial infusions of intravenous ketamine administered over 2 weeks.

Interventions

  • Ketamine0.5 mg/kg
    via IV• six infusions over 2 weeks• 6 doses total

    Initial dosing for first 5 participants was based on ideal body weight, then switched to actual body weight for subsequent participants.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment13 participants
  • Timeline
    Start: 2016-01-01
    End: 2018-01-01
  • Compound
    Ketamine

Related Publications

Open AccessindividualPrimary

Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study

This open-label study (n=13) probed into the efficacy and tolerability of intravenous ketamine in adolescents with treatment-resistant depression (TRD), and investigated clinical response predictors using the Children's Depression Rating Scale-Revised (CDRS-R) and the Clinician-Administered Dissociative States Scale (CADSS). It supported the potential of ketamine in the treatment of adolescent patients with TRD and a dose-response relationship but called for larger sample size and overcoming limitations such as the open-label design and further research.

Published
Journal
Journal of Child and Adolescent Psychopharmacology
Authors
Cullen, K. R., Amatya, P., Roback, M. G., Albott, C. S., Schreiner, M. W., Ren, Y., Eberly, L. E., Carstedt, P., Samikoglu, A., Gunlicks-Stoessel, M., Reigstad, K., Horek, N., Tye, S., Lim, K. O., Klimes-Dougan, B.