Intranasal Ketamine in Treatment-Resistant Depression

A study testing Ketamine in people with Major Depressive Disorder, run by James Murrough at 1 site in United States.

Completed

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

Trial summary

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD). Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Ketamine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Oct 2014
Phase: Interventional
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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients, 21-65 years;
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
Primary diagnosis of major depressive disorder as assessed by the SCID-P;
Current depressive episode;
History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Who cannot join

Women who plan to become pregnant, are pregnant or are breast-feeding;
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
Drug or alcohol abuse or dependence within the preceding 6 months;
Lifetime abuse or dependence on ketamine or phencyclidine;
Patients judged by study investigator to be at high risk for suicide.
Previous participation in a ketamine study at Mount Sinai

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Conditions: Major Depressive Disorder
Being tested: Ketamine, placebo
Keywords: ketamine, depression, treatment resistance, intranasal, antidepressant, glutamate, NMDA receptor
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

KetamineDrug
A single dose of intranasal ketamine up to 50 mg
placeboDrug
Single dose of saline intranasal

Study groups in NCT01304147
Study group	Role	What they receive
Ketamine	Experimental	Subjects randomized to this arm will receive the active study medication, intranasal ketamine. Receives: Drug: Ketamine
Placebo	Placebo comparator	Subjects randomized to this arm will receive intranasal saline. Receives: Drug: placebo

What is being measured

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

Montgomery-Asberg Depression Rating Scale (MADRS)
Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration
10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.
Measured: 24 hours

Secondary outcomes (1)

Systematic Assessment for Treatment Emergent Effects (SAFTEE)
This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.
Measured: 2 weeks

Timeline

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

Oct 2011Oct 2014

First posted25 Feb 2011 (estimated)
Study startOct 2011
Primary completionOct 2014
Study completionOct 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01304147
Sponsor's protocol ID: GCO 11-0492
Other IDs: INKET-001
Status last verified: Dec 2016
First submitted: 23 Feb 2011
Last updated: 8 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1016/j.biopsych.2014.03.026. Epub 2014 Apr 3.
PubMed 24821196
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411

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 of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
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Characterization and Treatment of Adolescent Depression
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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
ClinicalTrials.gov ID: NCT01304147
Acronym / sponsor ID: GCO 11-0492
Conditions: Major Depressive Disorder
Keywords: ketamine, depression, treatment resistance, intranasal, antidepressant, glutamate, NMDA receptor
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: James MurroughUniversity, hospital or other
Study start: Oct 2011
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 25 Feb 2011 (estimated)
Results: Posted 8 Feb 2017

Clinical summary

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

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ketamine	Experimental	Drug: KetamineSubjects randomized to this arm will receive the active study medication, intranasal ketamine.
Placebo	Placebo comparator	Drug: placeboSubjects randomized to this arm will receive intranasal saline.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female patients, 21-65 years;
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
Primary diagnosis of major depressive disorder as assessed by the SCID-P;
Current depressive episode;
History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;

Key exclusion criteria (8 listed)

Women who plan to become pregnant, are pregnant or are breast-feeding;
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
Drug or alcohol abuse or dependence within the preceding 6 months;

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
KetamineA single dose of intranasal ketamine up to 50 mg	Drug	Ketamine
placeboSingle dose of saline intranasal	Drug	Placebo

Primary outcome

Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 24 hours
Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.

1 secondary outcome

Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Time frame: 2 weeks

Results and safety

Results posted to the registry on 8 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketamine Then Placebo	10	10
Placebo, Then Ketamine	10	10

Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS)

Time frame: 24 hours. Number. Unit: participants

Measure	Ketamine n = 18	Placebo n = 18
Value	8	1

Ketamine vs Placebo: Mean Difference (Final Values): 7.6 (95% CI 3.9 to 11.3), p <0.001, Paired t-test, 2 sided

Population analysed: 20 patients randomized and 18 completed both treatment periods

1 secondary outcome is reported in the full results.

Adverse events

Time frame: within 24 hours following treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketamine	0 of 19 (0%)	19 of 19 (100%)	Not reported
Placebo	0 of 19 (0%)	19 of 19 (100%)	Not reported

Limitations and caveats (from the sponsor): Small sample size. Ongoing treatment with psychotropic medication allowed at stable doses makes it difficult to distinguish an intrinsic effect of ketamine from benefits resulting from the combination of ketamine with other antidepressant agents.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24821196Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1016/j.biopsych.2014.03.026. Epub 2014 Apr 3.
Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

Related trials for Major Depressive Disorder

RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
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RecruitingObservational study
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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.

James W Murrough, MD principal investigator

Icahn School of Medicine at Mount Sinai

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

Questions about this trial

What is this clinical trial studying?

A study testing Ketamine in people with Major Depressive Disorder, run by James Murrough 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 8 inclusion and 8 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 8 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2017). 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 (MADRS) (time frame: 24 hours). 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 NCT01304147, which also lists 2 linked publications.

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 8 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.