Ketamine + Mindfulness for Depression

Depression, Unipolar Clinical Trial

Official title:

Ketamine + Mindfulness for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05168735
• Other study ID #: STUDY21110040
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

All participants will:

1. be between the ages of 18 and 65 years,

2. score = 14 on the Hamilton Depression Rating Scale (modified Ham-D)

3. 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:

1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);

2. 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.

3. Changes made to treatment regimen within 4 weeks of baseline assessment.

4. Reading level <6th grade as per patient self-report.

5. Patients who have received ECT in the past 2 months prior to Screening.

6. Current pregnancy or breastfeeding

7. 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.

8. Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for unreported drugs of abuse], vitals, or ECG.

9. 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.

10. Patients with one or more seizures without a clear and resolved etiology.

11. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.

12. Past intolerance or hypersensitivity to ketamine.

13. 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.

14. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

15. Patients who report meditating with mindfulness techniques >1 hour weekly (on average) for the past 6 months or longer.

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder

Intervention

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
• Academic Exercises
30min of mental math and other academic cognitive puzzles completed silently/mentally

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rebecca Price

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sustained Attention Response Task (SART) omission errors	performance-based measure of mindful attention	infusion +24 hours (1 day)
Other	Sustained Attention Response Task (SART) self-reported task focus	self-report rating of being on-task (range: 1-7; higher score=more on-task)	infusion +24 hours (1 day)
Other	Awe Experience Scale	self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe)	infusion +80min
Other	Dual probe video task	attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films)	infusion +24 hours (1 day)
Primary	Montgomery-Asberg Depression Rating Scale	Clinician-rated depression (range: 0-60; higher scores = worse outcome)	24hrs post-intervention
Primary	Montgomery-Asberg Depression Rating Scale	Clinician-rated depression (range: 0-60; higher scores = worse outcome)	5 days post-intervention
Primary	Montgomery-Asberg Depression Rating Scale	Clinician-rated depression (range: 0-60; higher scores = worse outcome)	12 days post-intervention
Primary	Montgomery-Asberg Depression Rating Scale	Clinician-rated depression (range: 0-60; higher scores = worse outcome)	21 days post-intervention
Primary	Montgomery-Asberg Depression Rating Scale	Clinician-rated depression (range: 0-60; higher scores = worse outcome)	30 days post-intervention
Primary	State Mindfulness Scale	Self-reported mindfulness (range 21-105; higher scores = more mindfulness)	80min post-infusion
Secondary	modified Hamilton Depression Rating Scale	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	24hrs post-intervention
Secondary	modified Hamilton Depression Rating Scale	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	5 days post-intervention
Secondary	modified Hamilton Depression Rating Scale	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	12 days post-intervention
Secondary	modified Hamilton Depression Rating Scale	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	21 days post-intervention
Secondary	modified Hamilton Depression Rating Scale	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	30 days post-intervention
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	24hrs post-intervention
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	5 days post-intervention
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	12 days post-intervention
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	21 days post-intervention
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	30 days post-intervention
Secondary	Hood Mysticism Scale	clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)	infusion +40min
Secondary	Mindful Attention Awareness Scale	self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)	24hrs post-intervention
Secondary	Mindful Attention Awareness Scale	self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)	5 days post-intervention
Secondary	Mindful Attention Awareness Scale	self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)	12 days post-intervention
Secondary	Mindful Attention Awareness Scale	self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)	21 days post-intervention
Secondary	Mindful Attention Awareness Scale	self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)	30 days post-intervention
Secondary	Daily Spiritual Experience Scale	self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)	5 days post-intervention
Secondary	Daily Spiritual Experience Scale	self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)	12 days post-intervention
Secondary	Daily Spiritual Experience Scale	self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)	21 days post-intervention
Secondary	Daily Spiritual Experience Scale	self-reported spiritual experiences (range: 0-75; higher scores=greater spiritual experience)	30 days post-intervention