Depression, UnipolarPhase 1/2NCT05168735

Ketamine + Mindfulness for Depression

A Phase 1/2 study testing Intravenous Ketamine, Brief Mindfulness Exercises and Academic Exercises in people with Depression, Unipolar, run by Rebecca Price at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Unipolar
What is being tested?: Intravenous Ketamine, Brief Mindfulness Exercises and Academic Exercises
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2022to 1 Sep 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 16Show fewer

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, 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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Read the detailed description

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

Conditions: Depression, Unipolar
Being tested: Intravenous Ketamine, Brief Mindfulness Exercises, Academic Exercises
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous KetamineDrug
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Brief Mindfulness ExercisesBehavioural
30min guided training in mindfulness meditation immediately prior to infusion
Academic ExercisesBehavioural
30min of mental math and other academic cognitive puzzles completed silently/mentally

Study groups in NCT05168735
Study group	Role	What they receive
Intravenous Ketamine + Mindfulness Exercises	Experimental	Not described Receives: Drug: Intravenous Ketamine; Behavioral: Brief Mindfulness Exercises
Intravenous Ketamine + Academic Exercises	Active comparator	Not described Receives: Drug: Intravenous Ketamine; Behavioral: Academic Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 24hrs post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 5 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 12 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 21 days post-intervention
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Measured: 30 days post-intervention
State Mindfulness Scale
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
Measured: 80min post-infusion

Secondary outcomes (20)

Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 24hrs post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 5 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 12 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 21 days post-intervention
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: 30 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 24hrs post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 5 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 12 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 21 days post-intervention
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: 30 days post-intervention
Hood Mysticism Scale
clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)
Measured: 40 minutes post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Measured: 24hrs post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Measured: 5 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Measured: 12 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Measured: 21 days post-intervention
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Measured: 30 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Measured: 5 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Measured: 12 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Measured: 21 days post-intervention
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Measured: 30 days post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20221 Sep 2023

First posted23 Dec 2021
Study start1 Feb 2022
Primary completion1 Aug 2023
Study completion1 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depression, UnipolarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05168735
Sponsor's protocol ID: STUDY21110040
Status last verified: Jul 2024
First submitted: 9 Dec 2021
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40964432

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketamine + Mindfulness for Depression
ClinicalTrials.gov ID: NCT05168735
Acronym / sponsor ID: STUDY21110040
Conditions: Depression, Unipolar
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Rebecca PriceUniversity, hospital or other
Study start: 1 Feb 2022 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 23 Dec 2021 (actual)
Results: Posted 20 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intravenous Ketamine + Mindfulness Exercises	Experimental	Drug: Intravenous Ketamine, Behavioral: Brief Mindfulness Exercises
Intravenous Ketamine + Academic Exercises	Active comparator	Drug: Intravenous Ketamine, Behavioral: Academic Exercises

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous KetamineSingle infusion of intravenous racemic ketamine (0.5mg/kg over 40min)	Drug	Intravenous Ketamine + Academic Exercises, Intravenous Ketamine + Mindfulness Exercises
Brief Mindfulness Exercises30min guided training in mindfulness meditation immediately prior to infusion	Behavioural	Intravenous Ketamine + Mindfulness Exercises
Academic Exercises30min of mental math and other academic cognitive puzzles completed silently/mentally	Behavioural	Intravenous Ketamine + Academic Exercises

Primary outcome

Montgomery-Asberg Depression Rating Scale
Time frame: 24hrs post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Montgomery-Asberg Depression Rating Scale
Time frame: 5 days post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Montgomery-Asberg Depression Rating Scale
Time frame: 12 days post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Montgomery-Asberg Depression Rating Scale
Time frame: 21 days post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Montgomery-Asberg Depression Rating Scale
Time frame: 30 days post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
State Mindfulness Scale
Time frame: 80min post-infusion
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)

20 secondary outcomes

Modified Hamilton Depression Rating Scale
Time frame: 24hrs post-intervention
Modified Hamilton Depression Rating Scale
Time frame: 5 days post-intervention
Modified Hamilton Depression Rating Scale
Time frame: 12 days post-intervention
Modified Hamilton Depression Rating Scale
Time frame: 21 days post-intervention
Modified Hamilton Depression Rating Scale
Time frame: 30 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 24hrs post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 5 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 12 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 21 days post-intervention
Quick Inventory of Depressive Symptoms
Time frame: 30 days post-intervention
Hood Mysticism Scale
Time frame: 40 minutes post-intervention
Mindful Attention Awareness Scale
Time frame: 24hrs post-intervention
Mindful Attention Awareness Scale
Time frame: 5 days post-intervention
Mindful Attention Awareness Scale
Time frame: 12 days post-intervention
Mindful Attention Awareness Scale
Time frame: 21 days post-intervention
Mindful Attention Awareness Scale
Time frame: 30 days post-intervention
Daily Spiritual Experience Scale
Time frame: 5 days post-intervention
Daily Spiritual Experience Scale
Time frame: 12 days post-intervention
Daily Spiritual Experience Scale
Time frame: 21 days post-intervention
Daily Spiritual Experience Scale
Time frame: 30 days post-intervention

Results and safety

Results posted to the registry on 20 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Ketamine + Mindfulness Exercises	22	22
Intravenous Ketamine + Academic Exercises	21	21

Primary outcome: Montgomery-Asberg Depression Rating Scale

Time frame: 24hrs post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intravenous Ketamine + Mindfulness Exercises n = 20	Intravenous Ketamine + Academic Exercises n = 20
Value	12.50 (7.94)	13.30 (8.90)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery-Asberg Depression Rating Scale

Time frame: 5 days post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intravenous Ketamine + Mindfulness Exercises n = 21	Intravenous Ketamine + Academic Exercises n = 20
Value	15.81 (7.84)	14.30 (10.69)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery-Asberg Depression Rating Scale

Time frame: 12 days post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intravenous Ketamine + Mindfulness Exercises n = 21	Intravenous Ketamine + Academic Exercises n = 19
Value	15.43 (8.42)	17.21 (11.74)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery-Asberg Depression Rating Scale

Time frame: 21 days post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Intravenous Ketamine + Mindfulness Exercises n = 19	Intravenous Ketamine + Academic Exercises n = 20
Value	18.90 (11.71)	17.10 (11.39)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous Ketamine + Mindfulness Exercises	0 of 22 (0%)	22 of 22 (100%)	0 of 22
Intravenous Ketamine + Academic Exercises	0 of 21 (0%)	21 of 21 (100%)	0 of 21

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40964432Kheirkhah 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca Price, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intravenous Ketamine, Brief Mindfulness Exercises and Academic Exercises in people with Depression, Unipolar, run by Rebecca Price at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (time frame: 24hrs post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.