Major Depressive DisorderPhase 2NCT03658330
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
A Phase 2 study testing Ketamine + Naltrexone in people with Major Depressive Disorder and Alcohol Use Disorder, run by VA Connecticut Healthcare System.
Trial summary
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- Ketamine + Naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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, 21-65 years old
- Current major depressive disorder without psychotic features by DSM-5
- Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
- Current alcohol use disorder by DSM-5
- Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
- Abstinence from alcohol drinking for > 5 days prior to ketamine infusion
- Able to provide written informed consent
Who cannot join
- Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
- Current or past history of psychotic features or psychotic disorder
- Current or past history of delirium or dementia
- Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)
- Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
- Imminent suicidal or homicidal risk
Show all 10Show fewer
- Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
- Positive opioid or illicit drug screen test (except marijuana)
- Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
- Liver enzymes that are three times higher than the upper limit of normal
About this study
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.
Read the detailed description
The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- Ketamine + Naltrexone
- Keywords
- Ketamine, Naltrexone, Depression, Alcohol
- Medical subject headings
- Depressive Disorder, Major, Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + NaltrexoneDrug
Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Naltrexone | Experimental | Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection). Receives: Drug: Ketamine + Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Response is defined as a ≥ 50% improvement from baseline in MADRS scores. The MADRS has a total range of 0-60. Higher scores represent a worse outcome (i.e., more depression).
Measured: Day 21
Secondary outcomes (1)
Obsessive Compulsive Drinking Scale (OCDS)
The Obsessive Compulsive Drinking Scale is designed to assess alcohol craving and consumption. The scale has a total score range of 0-56. Higher scores represent a worse outcome (i.e., more alcohol problems).
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study startMay 2016
- Primary completionOct 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Gihyun Yoon, VA Connecticut Healthcare System
- Investigators
- Gihyun Yoon, MD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658330
- Sponsor's protocol ID
- GY0004
- Status last verified
- Sep 2018
- First submitted
- 1 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03658330
- Acronym / sponsor ID
- GY0004
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Keywords
- Ketamine, Naltrexone, Depression, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.
Detailed description
The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Naltrexone | Experimental | Drug: Ketamine + NaltrexoneSubjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 21-65 years old
- Current major depressive disorder without psychotic features by DSM-5
- Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
- Current alcohol use disorder by DSM-5
- Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
Key exclusion criteria (10 listed)
- Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
- Current or past history of psychotic features or psychotic disorder
- Current or past history of delirium or dementia
- Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)
- Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
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 |
|---|---|---|
| Ketamine + NaltrexoneSubjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection). | Drug | Ketamine + Naltrexone |
Primary outcome
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Day 21
Response is defined as a ≥ 50% improvement from baseline in MADRS scores. The MADRS has a total range of 0-60. Higher scores represent a worse outcome (i.e., more depression).
1 secondary outcome
Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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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.
Gihyun Yoon, MD principal investigator
VA Connecticut Healthcare System
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine + Naltrexone in people with Major Depressive Disorder and Alcohol Use Disorder, run by VA Connecticut Healthcare System.
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 7 inclusion and 10 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Day 21). 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 7 Sep 2018.