In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.
NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
30min guided training in mindfulness meditation immediately prior to infusion
30min of mental math and other academic cognitive puzzles completed silently/mentally
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 5 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 12 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 21 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 30 days post-intervention
State Mindfulness Scale
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
Time frame: 80min post-infusion
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
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Time frame: 5 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 12 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 21 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 30 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 5 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 12 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 21 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 30 days post-intervention
Hood Mysticism Scale
clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)
Time frame: 40 minutes post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 24hrs post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 5 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 12 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 21 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 30 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 5 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 12 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 21 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 30 days post-intervention