Clinical TrialDepressive DisordersKetamineActive not recruiting

Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment

This open-label trial (n=15) will assess the safety and tolerability of a single sub-anesthetic (0.5 mg/kg) intravenous ketamine treatment in individuals aged 50–90 with mild cognitive impairment and depression (MCI-D).

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label pilot study will evaluate safety and tolerability of a single 0.5 mg/kg IV ketamine infusion in older adults with mild cognitive impairment and clinically significant depression (MADRS ≥20).

Participants (n=15) undergo screening and baseline assessments including questionnaires, blood draw, cognitive testing, MRI (non-contrast) and optional EEG, receive one IV ketamine infusion, and are assessed at 1, 2, 3, 7, and 30 days post-infusion.

Primary outcomes are safety and tolerability; secondary and exploratory outcomes include changes in depression and cognition, imaging/connectivity measures, and the influence of amyloid biomarker status on response.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Treatment

experimental

Single dose of IV ketamine administered at the standard dose used for depression treatment (0.5 mg/kg).

Interventions

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

    Single IV infusion (0.5 mg/kg)

Participants

Ages
50 – 90
Sexes
Male & Female

Inclusion Criteria

  • Age 50-90
  • Able to give consent
  • Montgomery Asberg Depression Rating Scale (MADRS) score of ≥20 consistent with at least "moderate depression"
  • Clinical diagnosis of mild cognitive impairment or mild Alzheimer's Disease

Exclusion Criteria

  • Serious unstable medical illness
  • Uncontrolled hypertension
  • Abnormal electrocardiogram
  • Renal impairment defined as BUN 20 mg/dl and/or creatinine clearance >1.3
  • Current drug or alcohol use disorder
  • History of seizures without a clear or resolved etiology
  • Lifetime history of schizophrenia, schizoaffective disorder, or bipolar 1 or 2 disorder
  • Montreal Cognitive Assessment (MoCA) score <18
  • Presence of psychotic symptoms or lifetime psychotic disorder
  • Recreational ketamine or phencyclidine use in the last 2 years
  • BMI >40
  • Serious or imminent suicidal or homicidal risk
  • Systolic blood pressure >165 or diastolic blood pressure >95 on infusion day

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment15 participants
  • Timeline
    Start: 2023-10-18
    End: 2025-12-31
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center) — New York, New York, United States

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