RecruitingPhase 2NCT05641623

OSU6162 as add-on in SSRI/SNRI-resistant Depression

OSU6162 as add-on in SSRI/SNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety

Sponsor

Göteborg University

Enrollment

180 participants

Start Date

Apr 21, 2022

Study Type

INTERVENTIONAL

Conditions

Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Recurrent Depression Depressive Episode Recurrent Depressive Disorder

Summary

This is a randomised, placebo-controlled, parallel-group trial comparing OSU6162 at flexible dosage with placebo as add-on to treatment with an SSRI/SNRI in patients with depression that have not responded to treatment with an SSRI/SNRI per se for at least 6 weeks. The study will last for 6 weeks, after which those not having responded will leave the trial and those having responded will be offered to continue treatment without unblinding for another 4 weeks. Optional Substudy 1 and 2: Baseline and treatment-associated change in reward-related striatal activity per fMRI-assessment. (Substudy 1). Brain signal variability per fMRI-assessment. (Substudy 1). Probabilistic Reward Task (PRT). (Substudy 2). While assessment of the efficacy and safety of OSU6162 is the main objective of this study, possible differences between the two treatment groups with respect to a number of biomarkers in serum will also be explored. Multicenter trial: Multiple sites four Gothenburg, Lund, Stockholm and Uppsala.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called OSU6162 — which works on dopamine pathways in the brain — can help people with major depression who have not improved enough on standard antidepressants (SSRIs or SNRIs). **You may be eligible if...** - You are between 25 and 65 years old - You have a diagnosis of major depressive disorder (MDD) - You have been taking a standard antidepressant (such as sertraline, escitalopram, duloxetine, or venlafaxine) for at least 6 weeks without significant improvement - You had a period without depression within the past 2 years - Your depression score on a standard scale (MADRS ≥ 22) confirms moderate to severe depression **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or another psychotic condition - You are actively using illicit substances - You have serious physical health problems (heart, liver, kidney) - You are pregnant or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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