Ketamine + Mindfulness for Depression

NCT05168735 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STUDY21110040
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar

Outcome Measures

Primary Outcomes (6)

• Montgomery-Asberg Depression Rating Scale

  Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  24hrs post-intervention

• Montgomery-Asberg Depression Rating Scale

  Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  5 days post-intervention

• Montgomery-Asberg Depression Rating Scale

  Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  12 days post-intervention

• Montgomery-Asberg Depression Rating Scale

  Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  21 days post-intervention

• Montgomery-Asberg Depression Rating Scale

  Clinician-rated depression (range: 0-60; higher scores = worse outcome)

  30 days post-intervention

• State Mindfulness Scale

  Self-reported mindfulness (range 21-105; higher scores = more mindfulness)

  80min post-infusion

Secondary Outcomes (20)

• Modified Hamilton Depression Rating Scale

  24hrs post-intervention

• Modified Hamilton Depression Rating Scale

  5 days post-intervention

• Modified Hamilton Depression Rating Scale

  12 days post-intervention

• Modified Hamilton Depression Rating Scale

  21 days post-intervention

• Modified Hamilton Depression Rating Scale

  30 days post-intervention

Other Outcomes (7)

• Sustained Attention Response Task (SART) Omission Errors

  infusion +24 hours (1 day)

• Sustained Attention Response Task (SART) Self-reported Task Focus

  infusion +24 hours (1 day)

• Awe Experience Scale

  infusion +80min

Study Arms (2)

Intravenous Ketamine + Mindfulness Exercises

EXPERIMENTAL

Drug: Intravenous Ketamine; Behavioral: Brief Mindfulness Exercises

Intravenous Ketamine + Academic Exercises

ACTIVE COMPARATOR

Drug: Intravenous Ketamine; Behavioral: Academic Exercises

Interventions

Intravenous Ketamine DRUG

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

Intravenous Ketamine + Academic Exercises; Intravenous Ketamine + Mindfulness Exercises

Brief Mindfulness Exercises BEHAVIORAL

30min guided training in mindfulness meditation immediately prior to infusion

Intravenous Ketamine + Mindfulness Exercises

Academic Exercises BEHAVIORAL

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

Intravenous Ketamine + Academic Exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rebecca Price: lead

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 40964432 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Limitations and Caveats

Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.

Results Point of Contact

• Title: Dr. Rebecca Price
• Organization: University of Pittsburgh

pricerb@upmc.edu

412-383-2150

Study Officials

• Rebecca Price, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: February 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)