Neurobiology of Treatment Responses in MDD

NCT03068247 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 00095062
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• mu-opioid receptor binding capacity

  derived from PET scans

  10 weeks

• depression score

  HRSD-17 score

  10 weeks

Study Arms (2)

Interventional

EXPERIMENTAL

10 weeks of duloxetine beginning at 30 mg per day for week 1, then 60 mg / day thereafter.

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

10 weeks of placebo once daily for 1 week, then twice daily therafter.

Drug: Placebo

Interventions

Duloxetine DRUG

10 week treatment

Also known as: Cymbalta

Interventional

Placebo DRUG

10 week treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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);
• 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).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)