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.
Study Arms & Interventions
Ketamine infusion
experimentalSingle intravenous ketamine infusion in bipolar depressed patients receiving mood-stabilizing drugs.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
Performed between 8:00-8:45 h
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine infusionexperimental | 18 | — | — | — | — |
* 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
- StatusCompleted
- Typeinterventional
- DesignNon-randomized
- Target Enrollment18 participants
- TimelineStart: 2013-01-01End: 2014-12-31
- Compound