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.

Ask Blossom about this trial

Target Enrollment

13 participants

Study Type

interventional

Design

Non-randomized

Registry

CTG / NCT02078817

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.

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: September 1, 2018
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.

Company

Product

Legal