Clinical TrialKetamineCompleted

Single IV Ketamine for Bipolar Depression: Open Neurocognitive Pilot Study (Permoda-Osip / Rybakowski, Poznan Poland)

Open single-arm pilot study of a single IV ketamine infusion in bipolar depression with neurocognitive outcomes (Pharmacopsychiatry 2015 Mar; Permoda-Osip A, Kisielewski J, Bartkowska-Sniatkowska A, Rybakowski JK; Department of Adult Psychiatry, Poznan University of Medical Sciences, Poland; PMID 25347227; DOI 10.1055/s-0034-1394399). n=18 bipolar I/II inpatients with a depressive episode (HDRS-17 ≥18). Intervention: single IV ketamine 0.5 mg/kg over 40 min. Neurocognitive battery assessed at baseline and 7 days post-infusion: Wisconsin Card Sorting Test, Stroop Colour–Word Test, Trail Making Test A/B, verbal fluency. HDRS-17 assessed at baseline, day 1, and day 7. No control arm. No CT.gov registration; no registration number reported. CT.gov PMID reverse-lookup: 0 hits.

Target Enrollment
18 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine infusion

experimental

Single intravenous ketamine infusion in bipolar depressed patients receiving mood-stabilizing drugs.

Interventions

  • Ketamine0.5 mg/kg
    via IVsingle dose1 doses total

    Performed between 8:00-8:45 h

Primary Results(1 publication)

Participants

N = 18Mean age: 50 across armsA. et al. 2014

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamine infusionexperimental18

* Somatic and mental status were closely monitored during the procedure and within 6 consecutive hours. No specific adverse event counts (TEAEs, SAEs, etc.) were reported in this letter.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment18 participants
  • Timeline
    Start: 2013-01-01
    End: 2014-12-31
  • Compound

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