Treatment Resistant DepressionPhase 2/3NCT03923361
Neural and Antidepressant Effects of Propofol (Phase 2)
A Phase 2/3 study testing Diprivan in people with Treatment Resistant Depression, run by University of Utah at 1 site in United States.
Trial summary
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Diprivan
- 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
- 16 Apr 2019to Jul 2024
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- Diagnosis of major depressive disorder or bipolar disorder
- Current moderate-to-severe depressive episode
- Episode duration more than 2 months and less than 5 years
- Failure of at least 2 adequate antidepressant medication trials within the past 2 years
- Body mass index < 40
- 16-item Quick Inventory of Depressive Symptomatology, self-rated > 10
Who cannot join
- Contraindication to propofol or midazolam
- Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
- Symptomatic coronary artery disease or heart failure
- Poorly controlled hypertension or diabetes
- Abnormal kidney or liver function
- Pregnant or breast feeding
Show all 16Show fewer
- Traumatic brain injury or significant neurologic signs (past year)
- Substance use disorder (past year)
- Obsessive compulsive disorder (current)
- Post-traumatic stress disorder (current)
- Schizophrenia-spectrum disorder (lifetime)
- Neurocognitive disorder (current)
- Personality disorder as a current focus of treatment
- ECT within the past 3 months
- Inappropriate for ECT, or poor response to ECT within the past 5 years
- Incompetent to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy Neuropsychiatric Institute
Salt Lake City, Utah, 84108
About this study
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
- Conditions
- Treatment Resistant Depression
- Being tested
- Diprivan
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiprivanDrug
Also called Propofol
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Not described Receives: Drug: Diprivan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%
Measured: 3 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start16 Apr 2019
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Change in study design based on phase 1 data collection; patient burden was not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT03923361
- Sponsor's protocol ID
- 00116093B
- Status last verified
- Dec 2019
- First submitted
- 19 Apr 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Antidepressant Effects of Propofol (Phase 2)
- ClinicalTrials.gov ID
- NCT03923361
- Acronym / sponsor ID
- 00116093B
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study design based on phase 1 data collection; patient burden was not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Apr 2019 (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.
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Diprivan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-55
- Diagnosis of major depressive disorder or bipolar disorder
- Current moderate-to-severe depressive episode
- Episode duration more than 2 months and less than 5 years
- Failure of at least 2 adequate antidepressant medication trials within the past 2 years
Key exclusion criteria (16 listed)
- Contraindication to propofol or midazolam
- Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
- Symptomatic coronary artery disease or heart failure
- Poorly controlled hypertension or diabetes
- Abnormal kidney or liver function
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 |
|---|---|---|
| DiprivanAlso: PropofolSimilar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes. | Drug | Propofol |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 3 weeks after baseline
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%
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 18 Dec 2019.
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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 2/3 study testing Diprivan in people with Treatment Resistant Depression, 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 7 inclusion and 16 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 18 Dec 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 combined 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.
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 Rating Scale for Depression (time frame: 3 weeks after baseline). 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 18 Dec 2019.