Suicidal IdeationPhase 3NCT02532153
The Impact of Ketamine on the Reward Circuitry of Suicidal Patients
A Phase 3 study testing Ketamine Hydrochloride in people with Suicidal Ideation and Suicide, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide individual, financial, and societal burden of suicide-which is projected to rise in the coming decades-supporting the need for… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Suicide
- What is being tested?
- Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2017to 28 Feb 2017
- Phase
- Phase 3
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will:
- be ≥18 years old,
- read, understand, and provide written informed consent,
- have suicidal ideation for ≥ 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS),
- be on a stable psychiatric medication regimen for ≥28 days,
- maintain a treating doctor who is in agreement with study participation, and aware of the safety plan in the protocol,
Show all 15Show fewer
- 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.
- Healthy Controls will:
- be ≥18 years old,
- read, understand, and provide written informed consent,
- have a negative pregnancy test on the morning of the MRI (females only).
- be right handed.
Who cannot join
- Patients will be excluded if any of the following criteria are met:
- 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 or alter brain morphology (e.g., diabetes, hypertension, traumatic brain injury), even if well controlled on medications,
- history of multiple adverse drug reactions,
- active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine/PCP abuse,
Show all 19Show fewer
- requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, sedatives, theophylline, or St. John's Wort),
- BMI >35,
- pregnancy, breastfeeding, or unacceptable means of birth control (females only)
- presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
- concurrent participation in other research studies.
- Healthy controls will be excluded if any of the following criteria are met:
- current or past Axis I diagnosis, including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) and suicidal thoughts/attempts,
- 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., diabetes) even if controlled by medications,
- requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, benzodiazepines, sedatives, theophylline, or St. John's Wort),
- presence of psychiatric disorders in first-degree relatives,
- pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
- BMI >35.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Impact of Ketamine on the Reward Circuitry of Suicidal Patients: An MRI Study
Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide individual, financial, and societal burden of suicide-which is projected to rise in the coming decades-supporting the need for antisuicidal treatments.
This treatment gap may be filled through understanding the neurobiology of suicide, which can guide the development of targeted antisuicidal treatments. Though some research has examined the neurobiology of suicidal ideation in the context of depression-implicating the orbital frontal cortex, anterior cingulate cortex, and striatum-the underlying pathophysiology and neurobiology of suicidal ideation as a separate construct from depression remains largely unknown. Therefore, the investigators propose to study the neurocircuitry of suicidal thoughts, regardless of whether or not depression is present.
- Conditions
- Suicidal Ideation, Suicide
- Being tested
- Ketamine Hydrochloride
- Keywords
- Suicidal Ideation, Suicide, Suicidal Thoughts, Depression, Ketamine
- Medical subject headings
- Suicidal Ideation, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Single open-label infusions
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Ketamine | Other | Not described Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale (C-SSRS)
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionFeb 2017 (estimated)
- Study completion28 Feb 2017
Why it stopped: No funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn F Ionescu, Massachusetts General Hospital
- Investigators
- Dawn Ionescu, M.D., Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532153
- Sponsor's protocol ID
- 2015P001783
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No