CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Naltrexone 50 Mg Oral Tablet +1 moredrug
Likely dose
Naltrexone 50 Mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04322526
NCT04322526Phase 4Completed
CompareCT.gov

Naltrexone-induced Blockade of Neural Responses Induced by Fast-Acting Antidepressant Effects

Marta Peciña, MD PhD·interventional·Posted Mar 26, 2020·Updated Apr 21, 2020

In Brief

A Phase 4 clinical trial evaluating Naltrexone 50 Mg Oral Tablet and Placebo oral tablet for Depression and Major Depressive Disorder. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The goal of this study is to determine whether antidepressant placebo effects and contextual cues broadly, can be blocked by one single dose of the µ-opioid antagonist naltrexone. To test this hypothesis, un-medicated, patients with MDD completed a randomized, double-blind, placebo-controlled, cross-over study of 50mg of the µ-opioid antagonist naltrexone or matching placebo, immediately before a Pharmaco-fMRI scanning session.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Major Depressive Disorder
CountriesUnited States
CollaboratorsBrain & Behavior Research Foundation

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 26, 2020
Enrollment StartJul 1, 2017
Primary CompletionJul 15, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.3 years ago

Interventions

Naltrexone 50 Mg Oral Tabletdrug

Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~24 hours).

Placebo oral tabletdrug

Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet.