Clinical TrialTreatment-Resistant Depression (TRD)KetamineWithdrawn

Intravenous Ketamine Effects on Functional Neuroanatomy

Phase I single-group study (n=10) assessing neuroanatomical effects of intravenous ketamine in patients with treatment-resistant depression using pre- and post-treatment fMRI and perfusion measures.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This prospective Phase I study will evaluate durable neuroanatomical changes after clinician-prescribed intravenous ketamine in patients with treatment-resistant depression using structural T1, arterial spin labelling (ASL) and resting BOLD fMRI acquired one week before and two days after treatment.

Up to 10 patients meeting criteria for treatment-resistant depression will be enrolled. Ketamine will be injected per treating physician to achieve a dissociative state (dose individualised, reported range 75–1000 mg). Clinical measures include Beck Depression Inventory, Beck Anxiety Inventory and Brief Pain Inventory; imaging analyses will assess perfusion, neurovascular coupling and functional connectivity.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single-group prospective evaluation of intravenous ketamine in treatment-resistant depression with pre- and post-treatment neuroimaging.

Interventions

  • Ketamine75 - 1000 mg
    via IV• single dose• 1 doses total

    Dose individualised per clinician to achieve dissociative state (75–1000 mg).

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • In order for a subject to be considered for this study, the patient must have been diagnosed with treatment-resistant depression, meaning the patient failed three medications and has been suffering from moderate treatment-resistant depression for over 6 months, indicated by a Beck Depression Inventory score of 10 or above. The patient must have been prescribed ketamine as part of their treatment plan, completely independent of any research. The patient must be willing to comply with the study protocol.

Exclusion Criteria

  • Exclusion Criteria:
  • In order for a subject to be considered for this study, he/she may not have any of the following:
  • * Advanced stages of any terminal illness or any active cancer that requires chemotherapy
  • * Hepatic impairment
  • * Significant cytopenia
  • * Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
  • * Women who are pregnant, may become pregnant, or are breastfeeding
  • * Any counter indications to ketamine
  • * Subjects unable to give informed consent or in vulnerable categories, such as prisoners

Study Details

Locations

Neurological Associates of West Los Angeles — Santa Monica, California, United States

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