DepressionPhase 4NCT02544607
Ketamine for Depression: An MRI Study
A Phase 4 study testing Ketamine and Magnetic Resonance Imaging (MRI) in people with Depression and Anxious Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxious Depression, Major Depressive Disorder
- What is being tested?
- Ketamine and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 29 Dec 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients will:
- 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 for ≥ 4 weeks,
- have a history of ≥1 failed medication trial during the current depression
- be on a stable antidepressant and psychotherapy regimen for ≥28 days,
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- maintain a treating doctor who is in agreement with study participation,
- have a reliable chaperone 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),
- be right handed.
- Healthy Controls will:
- be 18-64 years old,
- read, understand, and provide written informed consent in English,
- have a reliable chaperone 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), and
- be right handed.
Who cannot join
- Patients will be excluded if any of the following criteria are met:
- 1) delirium or dementia diagnosis, 2) unstable medical illness or clinically significant laboratory results, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury), 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders, 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse, 7) requirement of excluded medications that may interact with ketamine, 8) weigh >250 lbs., 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only) 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 11) current serious suicidal or homicidal risk, or 12) concurrent participation in other research studies.
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- Healthy controls will be excluded if any of the following criteria are met:
- current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
- presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
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- presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),
- requirement of excluded medications that may interact with ketamine,
- presence of psychiatric disorders in first-degree relatives,
- pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
- weight >250 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression
Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
Read the detailed description
Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS). MRI data will also be analyzed to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
- Conditions
- Depression, Anxious Depression, Major Depressive Disorder
- Being tested
- Ketamine, Magnetic Resonance Imaging (MRI)
- Keywords
- Ketamine, Depression, Anxious Depression, MRI
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine Hydrochloride
Ketamine 0.5mg/kg over 40 minutes IV
Magnetic Resonance Imaging (MRI)Other
MRI technology will be used before and after ketamine for patients with depression
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + MRI | Experimental | All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI). Receives: Drug: Ketamine; Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms
Change will be calculated by difference between HDRS from Minute 0 to Minute 240.
Measured: 4 hours
Secondary outcomes (4)
Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Measured: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Measured: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Measured: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Cristina Cusin, MD, Massachusetts General Hospital
- Investigators
- Cristina Cusin, M.D., Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544607
- Sponsor's protocol ID
- 2015P001912
- Other IDs
- 24032
- Status last verified
- Apr 2019
- First submitted
- 4 Sep 2015
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression
- ClinicalTrials.gov ID
- NCT02544607
- Acronym / sponsor ID
- 2015P001912
- Conditions
- Depression, Anxious Depression, Major Depressive Disorder
- Keywords
- Ketamine, Depression, Anxious Depression, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Institutes of Health (NIH)
- Study start
- Mar 2016
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
Detailed description
Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS). MRI data will also be analyzed to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine + MRI | Experimental | Drug: Ketamine, Other: Magnetic Resonance Imaging (MRI)All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 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 for ≥ 4 weeks,
- have a history of ≥1 failed medication trial during the current depression
- be on a stable antidepressant and psychotherapy regimen for ≥28 days,
Key exclusion criteria (11 listed)
- 1) delirium or dementia diagnosis, 2) unstable medical illness or clinically significant laboratory results, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury), 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders, 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse, 7) requirement of excluded medications that may interact with ketamine, 8) weigh >250 lbs., 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only) 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 11) current serious suicidal or homicidal risk, or 12) concurrent participation in other research studies.
- ---------------------------------------------------------------------------------------
- current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
- presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
- presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),
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 HydrochlorideKetamine 0.5mg/kg over 40 minutes IV | Drug | Ketamine + MRI |
| Magnetic Resonance Imaging (MRI)MRI technology will be used before and after ketamine for patients with depression | Other | Ketamine + MRI |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
Time frame: 4 hours
Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms Change will be calculated by difference between HDRS from Minute 0 to Minute 240.
4 secondary outcomes
Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)
Time frame: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)
Time frame: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)
Time frame: 4 hours
Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MGH Depression Clinical and Research ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Survivorship
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.
Cristina Cusin, 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 Phase 4 study testing Ketamine and Magnetic Resonance Imaging (MRI) in people with Depression and Anxious 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 18 inclusion and 11 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 16 Apr 2019. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Mar 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?
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion. (time frame: 4 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 16 Apr 2019.