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.
Signed informed consent.
Age: 25-75 on the day of screening.
Meeting DSM-5 criteria for major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI).
A symptom-free period preceding the current episode within the past two years confirmed at interview.
Meeting MINI criteria at interview for suicidality, manic episode, hypomanic episode, bipolar I, bipolar II, bipolar unspecified, bipolar I with psychotic symptoms, panic disorder (current), agoraphobia, posttraumatic stress disorder, alcohol dependency, alcohol abuse, substance dependency (non-alcoholic), substance abuse (non-alcoholic), psychotic disorders, mood disorders with psychotic features, anorexia nervosa, bulimia nervosa, anorexia nervosa binge eating / purging type, or antisocial personality disorder.
A history of substance/alcohol abuse within 2 years prior to screening.
A previous diagnosis of a personality disorder, autism spectrum disorder, attention-deficit/hyperactivity disorder, or intellectual disability.
Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial.
Parallel
OSU6162
DrugOSU6162
Placebo
DrugPlacebo
Bech 6-item subscale of the Hamilton Depression Rating Scale (HDRS)
Change from baseline with respect to the total score of the investigator-rated Bech 6-item subscale of the Hamilton Depression Rating Scale (HDRS) at endpoint. Lower scores mean a better outcome.
Hamilton Depression Rating Scale (HDRS)
Number of participants displaying clinical response defined as ≥50% reduction in the total score of the investigator-rated Bech 6-item subscale of the HDRS. Number of participants displaying clinical remission defined as a sum rating of ≤4 in the total score of the investigator-rated Bech 6-item subscale of the HDRS. Change from baseline with respect to investigator-rated item 1 (depressed mood) of the HDRS. Change from baseline with respect to the total score of the investigator-rated HDRS. Lower scores mean a better outcome.
Investigator-rated Montgomery Åsberg Depression Rating Scale (MADRS)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
investigator-rated Clinical Global Impression - Severity scale (CGI-S)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Clinical Global Impression - Change scale (CGI-C)
Investigator rating. Lower scores mean a better outcome.
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Göteborg University
Lead sponsor
Arvid Carlsson Research AB
Collaborator
