Major Depressive DisorderPhase 1NCT02935647
Burst Suppression Anesthesia for Treatment of Severe Depression
A Phase 1 study testing Diprivan in people with Major Depressive Disorder, run by University of Utah at 1 site in United States.
Trial summary
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to Sep 2018
- Phase
- Phase 1
- 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
- • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression
- Failed at least 2 anti-depressant treatments and no ECT in past 6 months
- Age between 18-55 years
- BMI < 35
- Hamilton Rating Scale for Depression (HSRD) score > 18
- Quick Inventory of Depression Scale (QIDS) score > 10.
Who cannot join
- • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder
- Significant pre-morbid cognitive impairment
- Hypertension and current use of ACE inhibitor or AR blocker medications
- Symptomatic coronary artery disease or congestive heart failure
- History of transient ischemic or neurologic signs during the past year
- History of or susceptibility to malignant hyperthermia
Show all 11Show fewer
- Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
- Diabetes requiring insulin
- Poor kidney function
- Chronic use of benzodiazepines or opioids
- Individuals incompetent to provide consent (e.g. catatonic, psychotic).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Neuropsychiatric Institute
Salt Lake City, Utah, 84108
About this study
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.
Read the detailed description
Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Diprivan
- 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.
DiprivanDrug
Also called Propofol
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken. 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
Measured: 3 weeks
Secondary outcomes (1)
Quick Inventory of Depressive Symptoms
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT02935647
- Sponsor's protocol ID
- 00090838
- Status last verified
- May 2021
- First submitted
- 13 Oct 2016
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mickey BJ, White AT, Arp AM, Leonardi K, Torres MM, Larson AL, Odell DH, Whittingham SA, Beck MM, Jessop JE, Sakata DJ, Bushnell LA, Pierson MD, Solzbacher D, Kendrick EJ, Weeks HR 3rd, Light AR, Light KC, Tadler SC. Propofol for Treatment-Resistant Depression: A Pilot Study. Int J Neuropsychopharmacol. 2018 Dec 1;21(12):1079-1089. doi: 10.1093/ijnp/pyy085.
PubMed 30260415
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burst Suppression Anesthesia for Treatment of Severe Depression
- ClinicalTrials.gov ID
- NCT02935647
- Acronym / sponsor ID
- 00090838
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.
Detailed description
Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.
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: DiprivanParticipants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression
Key exclusion criteria (11 listed)
- • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder
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: Propofol | Drug | Propofol |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 3 weeks
1 secondary outcome
Quick Inventory of Depressive Symptoms
Time frame: 3 weeks
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 2 Jun 2021.
- Derived from this study: PubMed 30260415Mickey BJ, White AT, Arp AM, Leonardi K, Torres MM, Larson AL, Odell DH, Whittingham SA, Beck MM, Jessop JE, Sakata DJ, Bushnell LA, Pierson MD, Solzbacher D, Kendrick EJ, Weeks HR 3rd, Light AR, Light KC, Tadler SC. Propofol for Treatment-Resistant Depression: A Pilot Study. Int J Neuropsychopharmacol. 2018 Dec 1;21(12):1079-1089. doi: 10.1093/ijnp/pyy085.
- 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 1 study testing Diprivan 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 6 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 2 Jun 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Hamilton Rating Scale for Depression (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935647, which also lists 1 linked publication.
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 2 Jun 2021.