Ketamine + Mindfulness for Depression
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravenous Ketamine + Mindfulness Exercises
|
Drug: Intravenous Ketamine
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Behavioral: Brief Mindfulness Exercises
30min guided training in mindfulness meditation immediately prior to infusion
|
| Active Comparator: Intravenous Ketamine + Academic Exercises
|
Drug: Intravenous Ketamine
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Behavioral: Academic Exercises
30min of mental math and other academic cognitive puzzles completed silently/mentally
|
Outcome Measures
Primary Outcome Measures
- Montgomery-Asberg Depression Rating Scale [24hrs post-intervention]
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
- Montgomery-Asberg Depression Rating Scale [5 days post-intervention]
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
- Montgomery-Asberg Depression Rating Scale [12 days post-intervention]
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
- Montgomery-Asberg Depression Rating Scale [21 days post-intervention]
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
- Montgomery-Asberg Depression Rating Scale [30 days post-intervention]
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
- State Mindfulness Scale [5min post-exercises]
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
- State Mindfulness Scale [80min post-infusion]
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
Secondary Outcome Measures
- modified Hamilton Depression Rating Scale [24hrs post-intervention]
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
- modified Hamilton Depression Rating Scale [5 days post-intervention]
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
- modified Hamilton Depression Rating Scale [12 days post-intervention]
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
- modified Hamilton Depression Rating Scale [21 days post-intervention]
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
- modified Hamilton Depression Rating Scale [30 days post-intervention]
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
- Quick Inventory of Depressive Symptoms [24hrs post-intervention]
Self-reported depression (range: 0-27; higher scores = worse outcome)
- Quick Inventory of Depressive Symptoms [5 days post-intervention]
Self-reported depression (range: 0-27; higher scores = worse outcome)
- Quick Inventory of Depressive Symptoms [12 days post-intervention]
Self-reported depression (range: 0-27; higher scores = worse outcome)
- Quick Inventory of Depressive Symptoms [21 days post-intervention]
Self-reported depression (range: 0-27; higher scores = worse outcome)
- Quick Inventory of Depressive Symptoms [30 days post-intervention]
Self-reported depression (range: 0-27; higher scores = worse outcome)
- Hood Mysticism Scale [infusion +40min]
clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)
- Mindful Attention Awareness Scale [24hrs post-intervention]
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
- Mindful Attention Awareness Scale [5 days post-intervention]
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
- Mindful Attention Awareness Scale [12 days post-intervention]
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
- Mindful Attention Awareness Scale [21 days post-intervention]
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
- Mindful Attention Awareness Scale [30 days post-intervention]
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
- Daily Spiritual Experience Scale [5 days post-intervention]
self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)
- Daily Spiritual Experience Scale [12 days post-intervention]
self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)
- Daily Spiritual Experience Scale [21 days post-intervention]
self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)
- Daily Spiritual Experience Scale [30 days post-intervention]
self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)
Other Outcome Measures
- Sustained Attention Response Task (SART) omission errors [infusion +24 hours (1 day)]
performance-based measure of mindful attention
- Sustained Attention Response Task (SART) self-reported task focus [infusion +24 hours (1 day)]
self-report rating of being on-task (range: 1-7; higher score=more on-task)
- Awe Experience Scale [infusion +80min]
self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe)
- Dual probe video task [infusion +24 hours (1 day)]
attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films)
Eligibility Criteria
Criteria
Inclusion Criteria:
All participants will:
-
be between the ages of 18 and 65 years,
-
score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D)
-
possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Exclusion Criteria:
All participants:
-
Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
-
Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
-
Changes made to treatment regimen within 4 weeks of baseline assessment.
-
Reading level <6th grade as per patient self-report.
-
Patients who have received ECT in the past 2 months prior to Screening.
-
Current pregnancy or breastfeeding
-
Patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
-
Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for unreported drugs of abuse], vitals, or ECG.
-
Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
-
Patients with one or more seizures without a clear and resolved etiology.
-
Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
-
Past intolerance or hypersensitivity to ketamine.
-
Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [riluzole, amantadine, memantine, topiramate, dextromethorphan, Dcycloserinem, Sonata, Ambien, Lunesta, Acamprosate
], or the mu-opioid receptor [opiate medications--morphine, oxycodone, heroin, fentanyl)]. However, lamotrigine will not be a study exclusion given that it has been shown not to impact ketamine's safety profile or its antidepressant efficacy.
-
Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
-
Patients who report meditating with mindfulness techniques >1 hour weekly (on average) for the past 6 months or longer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Rebecca Price
Investigators
- Principal Investigator: Rebecca Price, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY21110040