Clinical TrialKetamineCompleted

Ketamine and Global Brain Connectivity in MDD: Open-Label fMRI Study (Abdallah 2017, Yale)

Open-label single-arm neuroimaging study with healthy control comparator (Neuropsychopharmacology 2017; Abdallah CG, Averill LA, Collins KA, Geha P et al.; Yale University / VA Connecticut Healthcare System; PMID 27604566). Participants: n=18 adults (21–65 yr) with DSM-IV MDD, IDS-CR ≥32, failed ≥2 adequate antidepressant trials; medication-free ≥1 week; plus n=25 healthy controls (no lifetime psychiatric illness). Single IV ketamine infusion (0.5 mg/kg over 40 min) for MDD participants; resting-state fMRI (3T Philips) at baseline and 24 h post-infusion; MADRS at baseline and 24 h by blinded rater. Global brain connectivity (GBCr) metric computed voxel-wise. Response defined as ≥50% MADRS reduction. CT.gov: 4 BACKGROUND citations only (all correctly rejected by type-filter); DataBankList: empty; no registration number in methods.

Target Enrollment
18 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

MDD Ketamine

experimental

Patients with Major Depressive Disorder (MDD) receiving a single intravenous infusion of ketamine.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    administered via infusion pump over 40 min

Healthy Control

no intervention

Healthy control subjects (HC) used for baseline comparison.

Primary Results(1 publication)

Participants

N = 43Mean age: 39–43 across armsG. et al. 2016 →

MADRS

Score at Timepoint

MDD Ketamine43.6Day 1·G. et al. 2016 →

Response Rates

≥50% reduction in MADRS scores

10/18(55.6%)·G. et al. 2016 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
MDD Ketamineexperimental18————
Healthy Controlno_intervention25————

* The paper focuses on neuroimaging (GBCr) and clinical response (MADRS) rather than reporting a summary table of adverse events. No specific TEAE counts were provided in the text or tables.

* Healthy control group; no adverse event data reported.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment18 participants
  • Timeline
    Start: 2013-01-01
    End: 2016-01-01
  • Compound
    Ketamine

Related Publications

Ketamine Treatment and Global Brain Connectivity in Major Depression

Published
Authors
Abdallah, C. G., Averill, L. A., Collins, K. A., Geha, P., Schwartz, J., Averill, C., Dewilde, K. E., Wong, E., Anticevic, A., Tang, C. Y., Iosifescu, D. V., Charney, D. S., Murrough, J. W.

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