DepressionNCT02669043
Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
A study testing Ketamine in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Feb 2017
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be 18-64 years old,
- read, understand, and provide written informed consent in English,
- meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) for ≥ 4 weeks,
- have a history ≥1 failed medication trial during the current depression,
- be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,
- maintain a treating doctor who is in agreement with study participation,
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- have a reliable chaperone to accompany them home following the completion of the ketamine infusion day,
- be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
- be of non-childbearing potential or use of an acceptable form of birth control (females only).
Who cannot join
- delirium or dementia diagnosis,
- unstable medical illness or clinically significant laboratory results,
- history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure >140/95 mmHg at Screening,
- history of multiple adverse drug reactions,
- current/past history of psychotic disorders, history of out-of-body feelings or derealization,
- active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP (phencyclidine) abuse (we will confirm this with collateral information from their doctor if necessary),
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- requirement of excluded medications that may interact with ketamine,
- caffeine or nicotine use within 1 hour of psychophysiology testing, or alcohol use within 1 day of testing,
- pregnancy, breastfeeding, or unacceptable means of birth control (females only)
- clinically significant hearing impairment,
- current serious suicidal or homicidal risk,
- concurrent participation in other research studies involving medications or other treatments,
- narrow angle glaucoma,
- acute intermittent porphyria history,
- history of seizures in the past 6 months, regardless of seizure type,
- hyperthyroidism or untreated hypothyroidism,
- airway instability or pulmonary disease with hypercarbia, or
- current or past cubital or carpal tunnel syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of depression within hours in many patients with "treatment-resistant" depression, has been associated with superior efficacy in those individuals with anxious compared with non-anxious depression. In order to understand this unique effect more fully, the current protocol is aimed at further delineating biomarkers of ketamine's effects among individuals with treatment-resistant anxious depression compared to those with nonanxious depression.
- Conditions
- Depression
- Being tested
- Ketamine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine Hydrochloride
Intravenous ketamine 0.5mg/kg over 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | All participants receive open-label ketamine Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS, HAM-D)
Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Funding ended.
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.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cristina Cusin, MD, Massachusetts General Hospital
- Investigators
- Dawn Ionescu, M.D., Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669043
- Sponsor's protocol ID
- 2015P002397
- Other IDs
- K23MH107776
- Status last verified
- Mar 2018
- First submitted
- 27 Jan 2016
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
- ClinicalTrials.gov ID
- NCT02669043
- Acronym / sponsor ID
- 2015P002397
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of depression within hours in many patients with "treatment-resistant" depression, has been associated with superior efficacy in those individuals with anxious compared with non-anxious depression. In order to understand this unique effect more fully, the current protocol is aimed at further delineating biomarkers of ketamine's effects among individuals with treatment-resistant anxious depression compared to those with nonanxious depression.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineAll participants receive open-label ketamine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- be 18-64 years old,
- read, understand, and provide written informed consent in English,
- meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) for ≥ 4 weeks,
- have a history ≥1 failed medication trial during the current depression,
- be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,
Key exclusion criteria (18 listed)
- delirium or dementia diagnosis,
- unstable medical illness or clinically significant laboratory results,
- history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure >140/95 mmHg at Screening,
- history of multiple adverse drug reactions,
- current/past history of psychotic disorders, history of out-of-body feelings or derealization,
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 |
|---|---|---|
| KetamineAlso: Ketamine HydrochlorideIntravenous ketamine 0.5mg/kg over 40 minutes | Drug | Ketamine |
Primary outcome
Hamilton Depression Rating Scale (HDRS, HAM-D)
Time frame: 48 hours
Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dawn Ionescu, M.D. principal investigator
MGH
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 Depression, run by Massachusetts General Hospital 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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 23 Apr 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 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?
Hamilton Depression Rating Scale (HDRS, HAM-D) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2018.