Ketamine + Mindfulness for Depression

NCT ID: NCT05168735

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-09-01

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.

Detailed Description

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

Conditions

Depression, Unipolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intravenous Ketamine + Mindfulness Exercises

Group Type: EXPERIMENTAL

Intravenous Ketamine

Intervention Type: DRUG

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Brief Mindfulness Exercises

Intervention Type: BEHAVIORAL

30min guided training in mindfulness meditation immediately prior to infusion

Intravenous Ketamine + Academic Exercises

Group Type: ACTIVE_COMPARATOR

Intravenous Ketamine

Intervention Type: DRUG

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Academic Exercises

Intervention Type: BEHAVIORAL

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

Interventions

Intravenous Ketamine

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Intervention Type: DRUG

Brief Mindfulness Exercises

30min guided training in mindfulness meditation immediately prior to infusion

Intervention Type: BEHAVIORAL

Academic Exercises

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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);

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, D-cycloserine], 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebecca Price

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Price

Associate Professor of Psychiatry and Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rebecca Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Kheirkhah M, McDonald N, Aepfelbacher J, Rengasamy ML, Shivanekar S, Spotts C, Cooper I, Baumeister A, Bell E, Do-Nguyen K, Woody ML, Hossein S, Henter ID, Nugent AC, Hejazi NS, Jamalabadi H, Yavi M, Walter M, Zarate CA Jr, Price RB. Mindfulness, music, visual occlusion in ketamine therapy for depression: do they change outcomes? A qualitative and quantitative analysis of a randomized controlled trial. Front Psychiatry. 2025 Sep 2;16:1642025. doi: 10.3389/fpsyt.2025.1642025. eCollection 2025.

Reference Type: DERIVED

PMID: 40964432 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY21110040

Identifier Type: -

Identifier Source: org_study_id