Major Depressive DisorderPhase 3NCT03051945
Endogenous Opioid Modulation by Ketamine
A Phase 3 study testing Ketamine Hydrochloride and Normal saline in people with Major Depressive Disorder, run by University of Utah at 1 site in United States.
Trial summary
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine Hydrochloride and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to 1 Aug 2019
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- DSM-5 major depressive disorder
- Current moderate-to-severe, treatment-resistant, depressive episode
- Patient Health Questionnaire (PHQ-9) total score ≥ 10
- PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
- PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
- Medical documentation of depression for at least 2 months
- Inadequate response to at least one adequate antidepressant medication trial in the current episode
Who cannot join
- Current episode duration >5 years
- Moderate-to-severe DSM-5 substance use disorder (past year)
- Cognitive disorder (past year)
- Post-traumatic stress disorder (past year)
- Obsessive compulsive disorder (past year)
- Personality disorder (past year)
Show all 15Show fewer
- Positive urine drug screen
- Psychotic symptoms
- Mania
- Significant neurologic disorder or injury
- Breastfeeding or pregnancy
- Imminent suicide risk
- Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
- Other unstable psychiatric or medical condition requiring a higher level of care
- Contraindication to ketamine, MRI, or PET
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
Read the detailed description
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine Hydrochloride, Normal saline
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
Normal salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). Receives: Drug: Ketamine Hydrochloride |
| Placebo | Placebo comparator | Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale at 24 hours, change from baseline
total score on the 17-item Hamilton Depression Rating Scale
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startAug 2019 (estimated)
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Unable to perform brain imaging
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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Mickey, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051945
- Sponsor's protocol ID
- 00087544
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Opioid Modulation by Ketamine
- ClinicalTrials.gov ID
- NCT03051945
- Acronym / sponsor ID
- 00087544
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to perform brain imaging
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 Feb 2017 (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.
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
Detailed description
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine HydrochlorideKetamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). |
| Placebo | Placebo comparator | Other: Normal salineNormal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65
- DSM-5 major depressive disorder
- Current moderate-to-severe, treatment-resistant, depressive episode
- Patient Health Questionnaire (PHQ-9) total score ≥ 10
- PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
Key exclusion criteria (15 listed)
- Current episode duration >5 years
- Moderate-to-severe DSM-5 substance use disorder (past year)
- Cognitive disorder (past year)
- Post-traumatic stress disorder (past year)
- Obsessive compulsive disorder (past year)
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 HydrochlorideStudy drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances. | Drug | Ketamine |
| Normal salinePlacebo | Other | Placebo |
Primary outcome
Hamilton Depression Rating Scale at 24 hours, change from baseline
Time frame: 24 hr
total score on the 17-item Hamilton Depression Rating Scale
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine Hydrochloride and Normal saline in people with Major Depressive Disorder, run by University of Utah 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 15 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: withdrawn, as of the sponsor's last update on 28 Jan 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 at 24 hours, change from baseline (time frame: 24 hr). 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 28 Jan 2020.