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

NCT05641623 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-24

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

OSU6162

OSU6162

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Arvid Carlsson Research AB

    collaborator INDUSTRY

  • Göteborg University

    lead OTHER

Principal Investigators

  • Elias Eriksson, Professor · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2026-05-31
Completion
2026-08-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641623 on ClinicalTrials.gov