Trials / Recruiting

RecruitingNCT05641623

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 180 (estimated)

Sponsor: Göteborg University · Academic / Other
Sex: All
Age: 25 Years – 65 Years
Healthy volunteers: Not accepted

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.

Detailed description

The treatment period will be 6 weeks during which all subjects will make 7 study visits and be in contact with study nurse or physician by phone at 4 occasions. The first visit is a screening visit followed by a baseline visit for inclusion and start of treatment with OSU6162 or placebo. Optional for the subjects 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). Those responding to treatment will be offered to participate in the extension phase of the study for an additional 4 weeks during which the subjects will make 3 study visits and take 3 telephone interviews. Before inclusion in the study, all subjects will be informed both verbally and in writing about its purpose, its procedures, and possible risks associated with participation. Before any study-specific procedures take place, written informed consent will be obtained. Multicenter trial. Multiple sites 4: Sahlgrenska University Hospital Gothenburg, Skåne University Hospital Psychiatry Lund, North Stockholm psychiatry Stockholm region and Uppsala University Hospital Department of neuroscience Uppsala. For participation in the extension phase, four factors must be fulfilled: 1. The subject must regard himself/herself as clearly improved and be willing to continue. 2. The investigator must assess the subject as clearly improved. 3. The subject must display at least 50% reduction on HDRS6 as compared to baseline. 4. The subject must have signed a new informed consent. 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. The primary evaluation of efficacy will be undertaken at the endpoint of the 6-week trial. All analyses will however be repeated also at the endpoint of the 4-week extension phase for subjects participating in this part of the study. Data will be analysed using mixed models for repeated measurement which means that the model includes data from all depression ratings from baseline to endpoint; this method, which is usually recommended to be used in depression trials by the authorities, is considered to handle data loss due to patients leaving a study prematurely in a better way than imputation methods such as the last observation carried forward (LOCF) technique.

Conditions

Interventions

Type	Name	Description
DRUG	OSU6162	OSU6162
DRUG	Placebo	Placebo

Timeline

Start date: 2022-04-21
Primary completion: 2026-05-31
Completion: 2026-08-31
First posted: 2022-12-07
Last updated: 2025-03-24

Locations

4 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05641623. Inclusion in this directory is not an endorsement.