NCT03068247

Neurobiology of Treatment Responses in MDD

Neurobiology of Non-Specific and Specific Treatment Responses in Major Depression

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Duloxetine	10 week treatment
DRUG	Placebo	10 week treatment

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2017-03-01
• Last updated: 2023-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study