NCT05641623 OSU6162 as add-on in SSRI/SNRI-resistant Depression
| NCT ID | NCT05641623 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Göteborg University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-04-21 |
| Primary Completion | 2026-05-31 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria In order to be included in the study, subjects must meet the following criteria: 1. Signed informed consent. 2. Age: 25-65 on the day of screening. 3. Meeting DSM-5 criteria for major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI). 4. A symptom-free period preceding the current episode within the past two years confirmed at interview. 5. Not significantly improved, as judged by both doctor and patient, after having been treated with one of the following SSRIs/SNRIs: citalopram, escitalopram, paroxetine, sertraline, fluoxetine, duloxetine, or venlafaxine for at least 6 weeks. 6. Displaying a sum score of MADRS ≥22. 7. In women of childbearing potential (WOCBP): negative result of a pregnancy test and a method of contraception with a failure rate of less than 1 %. Contraception must be used during the treatment and follow-up period. Acceptable forms of contraception are: 1. Use of combined (estrogen and progestogen containi
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