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

Depression Clinical Trial

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

Status Recruiting

Clinical Trial 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.

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.

Clinical Trial Description

The treatment period will be 6 weeks during which all patients 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.

Those responding to treatment will be offered to participate in the extension phase of the study for an additional 4 weeks during which the patients will make 3 study visits and take 3 telephone interviews.

Before inclusion in the study, all patients 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, Karolinska Institutet Clinical Neuroscience Stockholm and Uppsala University Hospital Department of neuroscience Uppsala.

For participation in the extension phase, four factors must be fulfilled: 1. The patient must regard himself/herself as clearly improved and be willing to continue. 2. The investigator must assess the patient as clearly improved. 3. The patient must display at least 50% reduction on HDRS6 as compared to baseline. 4. The patient 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05641623
• Study type: Interventional
• Source: Göteborg University
• Contact: Elias Eriksson, Professor
• Phone: +46 709 555055
• Email: elias.eriksson@neuro.gu.se
• Status: Recruiting
• Phase: Phase 2
• Start date: April 21, 2022
• Completion date: August 31, 2026