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

Study acronym: ODEN
StatusRecruiting
PhasePhase 2
Started2022-04-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 36 months later May 31, 2026 → May 31, 2029
See other at-risk trials from Göteborg University

Amendment history

2026-09-16
Primary completion pushed: 2026-05-31 → 2029-05-31
Completion pushed: 2026-08-31 → 2029-12-31
2025-03-19
Study Identification, Study Status, Study Description, Contacts/Locations v2
Study description+253 characters
The treatment period will be 6 weeks during which all patientssubjects will make 7 study visits and be in contact with study nurse [...] r 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 [...] ase of the study for an additional 4 weeks during which the patientssubjects will make [...] [...]
Study sites4 entries, revised
KarolinskaNorth InstitutetStockholm Clinicalpsychiatry NeuroscienceStockholm region
2023-10-02
Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v1
Enrollment target72→180
Study sites1→4
Eligibility criteria+387 characters
Inclusion Criteria In order to be included in the study, subjects must meet the following criteria: Signed informed consent. Age: 25-65 on the day of screenin [...] m-free period preceding the current episode within the past yeartwo years confirmed at interview. Not significantly improved, as judg [...] is the sole sexual partner of the WOCBP trial participant). Sexual abstinence. Male patients must agree to use condoms during the study and [...] ient method of contraception, as described above. Exclusion Criteriacriteria Subjects must not be included in the study if any of the following criteria are met: Meeting [...] [...]
Study description+246 characters
[...] ures 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 [...]
2022-12-06
Original filing
Göteborg University
73 trials monitored
See 6 trials at risk
Depression
2,976 trials monitored
See 162 trials at risk
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.
Trial Details
NCT Number NCT05641623
Lead Sponsor Göteborg University
Collaborators: Arvid Carlsson Research AB
Conditions Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Depressive Episode, Recurrent Depressive Disorder, Recurrent Depression
Enrollment 180 participants
Start Date 2022-04-21
Primary Completion 2029-05-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15