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Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients (MOODBOOSTER)

Not yet recruitingRegisteredCTG

This randomised, quadruple-blind, placebo-controlled Phase III trial (n=60) will study the early effects of ketamine compared to placebo as an adjunctive therapy with venlafaxine in inpatients with severe unipolar major depressive disorder (MDD).

Details

Randomised, quadruple-blind, parallel-group Phase III trial in hospitalized adults with severe unipolar MDE (HDRS ≥24) comparing three IV ketamine infusions (0.5 mg/kg on Days 1, 4 and 7) versus matching saline placebo, both given adjunctive to venlafaxine.

Primary aim is to assess early antidepressant effects and safety; an ancillary PET-MRI study using [11C]UCB-J will assess synaptic density changes in a subset, with additional imaging-specific eligibility criteria.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT06508710