Clinical TrialKetamineCompleted

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

Single-arm open-label pilot (J Child Adolesc Psychopharmacol 2018; Cullen KR, Amatya P, Roback MG, Albott CS; University of Minnesota Medical School; PMID 30004254). Participants: 13 adolescents aged 12–18 with MDD and TRD (failure to respond to ≥2 adequate antidepressant trials; baseline CDRS-R raw score >40). No control arm, no randomisation. Intervention: six IV ketamine infusions at 0.5 mg/kg over 40 minutes on alternate weekdays over 2 weeks (dosing switched from ideal to actual body weight after first five participants showed no response with ideal-weight dosing). Primary outcome: percent change in CDRS-R from baseline to day following final infusion (response: ≥50% reduction; remission: CDRS-R ≤28). Responders invited for six weekly follow-up visits. IRB-approved; single centre. CT.gov: no valid hit; PubMed DataBankList: empty; no registration number identified in methods text.

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.

Primary Results(1 publication)

Participants

N = 13Mean age: 16.9 across armsR. et al. 2018 →

CDRS-R

Score at Timepoint

Ketamine44.1 (±16.3) [35.24, 52.96]Day 15·R. et al. 2018 →

Response Rates

≥50% reduction in depression symptoms

5/13(38.5%)·R. et al. 2018 →

CDRS-R score ≤28 (remission)

3/13(23.1%)·R. et al. 2018 →
3/13(23.1%)·R. et al. 2018 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental13——0(0.0%)1(7.7%)

* One participant dropped out before receiving infusions. Adverse effects reported included transient blood pressure changes, elevated CADSS scores (dissociative symptoms), dysphoria (2 participants), nausea (3 participants), and hand pain from catheter placement (1 participant). No respiratory adverse effects or serious adverse events were reported. One participant reported high suicidality, but clinical assessments did not reveal a change.

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

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

Published
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.

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