Back to resultsNeurobiology of Treatment Responses in MDD
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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).
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventional
Placebo
Arm Description
10 weeks of duloxetine beginning at 30 mg per day for week 1, then 60 mg / day thereafter.
10 weeks of placebo once daily for 1 week, then twice daily therafter.
Outcomes
Primary Outcome Measures
mu-opioid receptor binding capacity
derived from PET scans
depression score
HRSD-17 score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03068247
Brief Title
Neurobiology of Treatment Responses in MDD
Official Title
Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Institution was unable to manufacture radiotracer that was central to the protocol. Study transferred to another institution.
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
10 weeks of duloxetine beginning at 30 mg per day for week 1, then 60 mg / day thereafter.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 weeks of placebo once daily for 1 week, then twice daily therafter.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
10 week treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 week treatment
Primary Outcome Measure Information:
Title
mu-opioid receptor binding capacity
Description
derived from PET scans
Time Frame
10 weeks
Title
depression score
Description
HRSD-17 score
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
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).
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Neurobiology of Treatment Responses in MDD
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