Major Depressive DisorderPhase 3NCT03068247
Neurobiology of Treatment Responses in MDD
A Phase 3 study testing Duloxetine in people with Major Depressive Disorder, run by University of Utah at 1 site in United States.
Trial summary
The primary study intent is to examine biological mechanisms associated with acute and chronic treatment responses in major depressive disorder (MDD). It is hypothesized that treatment responsiveness, representing endogenous opioid system function, will be associated with acute improvements in mood state over a… 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?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to May 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet DSM V criteria for Major Depressive Episode, single episode or recurrent, for at least a month;
- Unmedicated for at least 10 half-lives of the previous AD used;
- Willing to limit the introduction of any new treatments during the study;
- 18 - 55 years of age;
- Right handed;
- Capable of giving written informed consent;
- Hamilton Depression Rating Scale (17-item HDRS, not including atypical features) >15 at screening and randomization;
Who cannot join
- Major medical illness (e.g., cancer, HIV, Hepatitis C, etc.) or concurrent, untreated, or symptomatic medical illnesses, including acute or ongoing pain, autoimmune or inflammatory disease;
- Use of narcotic analgesics within the last 6 months or regular use of sleeping aids (including benzodiazepines and related compounds), more than twice a week;
- Recent history of substance abuse (within the last 6 months) or history of substance dependence (lifetime);
- Other comorbid psychiatric illnesses, such as Bipolar Disorder, Obsessive Compulsive Disorder, Panic Disorder, any psychosis, or Axis II diagnoses. Generalized Anxiety and Social Anxiety Disorders will NOT be considered exclusionary given their common association with MDD
- Concurrent participation in other therapeutic trials;
- Pregnancy/nursing;
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- Ongoing treatment with medications with psychotropic properties;
- Contraindications to PET or MRI methods;
- Impairments, activities or situations that would prevent completion of the study protocol;
- Prior non-response to duloxetine;
- Active suicidal ideation.
- Urine screens positive for opioids or any substances of abuse.
- Allergy to fentanyl (because of structural similarity to the radiotracer [11C]carfentanil to be employed in the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression
The primary study intent is to examine biological mechanisms associated with acute and chronic treatment responses in major depressive disorder (MDD). It is hypothesized that treatment responsiveness, representing endogenous opioid system function, will be associated with acute improvements in mood state over a 10-week treatment trial in MDD. Potential (bio) markers of treatment effects will be tested against psychophysical responses to placebo and active treatments.
Read the detailed description
Volunteers will be randomized to receive placebo pills or a commercially available SNRI for 10 weeks. Volunteers will undergo imaging with structural and functional MRI and PET with [11C]carfentanil to determine baseline μOR BPND and changes in BPND measures during acute i.v. medication administration at the time of scanning before and after the 10-week treatment period.
To elicit the activation of µ-opioid-mediated neurotransmission in the scanner, we utilize the introduction of medication (active or inactive) 1mL into an intravenous port every 4 minutes, 15 sec per infusion, starting 45 minutes after radiotracer administration, until scan completion. Participants are made aware that the study drug will be administered at the time a computer-generated human voice recording reads a second-by-second count of the infusion timing (15 sec).
- Conditions
- Major Depressive Disorder
- Being tested
- Duloxetine, Placebo
- 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.
DuloxetineDrug
Also called Cymbalta
10 week treatment
PlaceboDrug
10 week treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 10 weeks of duloxetine beginning at 30 mg per day for week 1, then 60 mg / day thereafter. Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | 10 weeks of placebo once daily for 1 week, then twice daily therafter. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mu-opioid receptor binding capacity
derived from PET scans
Measured: 10 weeks
depression score
HRSD-17 score
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startNov 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Institution was unable to manufacture radiotracer that was central to the protocol. Study transferred to another institution.
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.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068247
- Sponsor's protocol ID
- 00095062
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2017
- Last updated
- 24 Apr 2023
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression
- ClinicalTrials.gov ID
- NCT03068247
- Acronym / sponsor ID
- 00095062
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institution was unable to manufacture radiotracer that was central to the protocol. Study transferred to another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 1 Mar 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.
The primary study intent is to examine biological mechanisms associated with acute and chronic treatment responses in major depressive disorder (MDD). It is hypothesized that treatment responsiveness, representing endogenous opioid system function, will be associated with acute improvements in mood state over a 10-week treatment trial in MDD. Potential (bio) markers of treatment effects will be tested against psychophysical responses to placebo and active treatments.
Detailed description
Volunteers will be randomized to receive placebo pills or a commercially available SNRI for 10 weeks. Volunteers will undergo imaging with structural and functional MRI and PET with [11C]carfentanil to determine baseline μOR BPND and changes in BPND measures during acute i.v. medication administration at the time of scanning before and after the 10-week treatment period.
To elicit the activation of µ-opioid-mediated neurotransmission in the scanner, we utilize the introduction of medication (active or inactive) 1mL into an intravenous port every 4 minutes, 15 sec per infusion, starting 45 minutes after radiotracer administration, until scan completion. Participants are made aware that the study drug will be administered at the time a computer-generated human voice recording reads a second-by-second count of the infusion timing (15 sec).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: Duloxetine10 weeks of duloxetine beginning at 30 mg per day for week 1, then 60 mg / day thereafter. |
| Placebo | Placebo comparator | Drug: Placebo10 weeks of placebo once daily for 1 week, then twice daily therafter. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meet DSM V criteria for Major Depressive Episode, single episode or recurrent, for at least a month;
- Unmedicated for at least 10 half-lives of the previous AD used;
- Willing to limit the introduction of any new treatments during the study;
- 18 - 55 years of age;
- Right handed;
Key exclusion criteria (13 listed)
- Major medical illness (e.g., cancer, HIV, Hepatitis C, etc.) or concurrent, untreated, or symptomatic medical illnesses, including acute or ongoing pain, autoimmune or inflammatory disease;
- Use of narcotic analgesics within the last 6 months or regular use of sleeping aids (including benzodiazepines and related compounds), more than twice a week;
- Recent history of substance abuse (within the last 6 months) or history of substance dependence (lifetime);
- Other comorbid psychiatric illnesses, such as Bipolar Disorder, Obsessive Compulsive Disorder, Panic Disorder, any psychosis, or Axis II diagnoses. Generalized Anxiety and Social Anxiety Disorders will NOT be considered exclusionary given their common association with MDD
- Concurrent participation in other therapeutic trials;
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 |
|---|---|---|
| DuloxetineAlso: Cymbalta10 week treatment | Drug | Interventional |
| Placebo10 week treatment | Drug | Placebo |
Primary outcome
mu-opioid receptor binding capacity
Time frame: 10 weeks
derived from PET scans
depression score
Time frame: 10 weeks
HRSD-17 score
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 24 Apr 2023.
- 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 Duloxetine 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 7 inclusion and 13 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 24 Apr 2023. 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?
mu-opioid receptor binding capacity (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 24 Apr 2023.