Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboTerminated

A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder

Interventional study in MDD (n≈12–13) assessing SEPs/MEPs as markers of cortical plasticity after a single IV ketamine infusion (0.5 mg/kg over 40 minutes); includes an initial open-label cohort and a randomized, double-blind, placebo-controlled cohort.

Target Enrollment
13 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

This study tests whether somatosensory and motor evoked potentials measured by EEG and EMG detect cortical plasticity changes in responders versus non-responders to a single IV ketamine infusion (0.5 mg/kg over 40 minutes).

Design: two sequential cohorts — Cohort 1 open-label (12 patients) and Cohort 2 randomized, double-blind, placebo-controlled (multicentre, ~20 planned); each patient undergoes screening, treatment phase (up to 4 weeks), optional open-label treatment, and follow-up, with safety monitoring throughout.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine IV

experimental

Single IV ketamine infusion (0.5 mg/kg) over 40 minutes; open-label option after double-blind phase.

Interventions

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

    Infusion over 40 minutes; optional open-label ketamine dose allowed after blinded phase.

Placebo IV

inactive

Single IV placebo infusion over 40 minutes (double-blind cohort).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Placebo infusion matched to ketamine for double-blind cohort; optional open-label ketamine after blinded phase.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patient must be medically stable
  • Patient must meet Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI)
  • Patient must have had an inadequate response to at least 2 antidepressants, one of which is in the current episode of depression
  • Patient must have an Inventory of Depressive Symptomatology 30-item Clinician-rated (IDS-C30) total score ≥ 34 at Screening and Day -1
  • Women must be postmenopausal, surgically sterile, or, if heterosexually active, practicing a highly effective method of birth control
  • Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria

  • Exclusion Criteria:
  • Patient has current signs and/or symptoms of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances
  • Patient has a primary DSM-IV diagnosis of current (active) generalized anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa
  • Patient has a current diagnosis of bipolar disorder, mental retardation, or cluster b personality disorder (e.g., borderline personality disorders, antisocial personality disorder, etc)
  • Patient has a current or prior diagnosis of a psychotic disorder or MDD with psychosis
  • Patient has not responded to treatment with electroconvulsive therapy (ECT) in the current episode of depression
  • Patient has suicidal ideation with intent to act, or has homicidal ideation/intent, during Screening phase per Investigator's clinical judgment
  • Patient has any significant primary sleep disorder

Study Details

Locations

Unknown facility — Durham, North Carolina, United States

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