Actively Recruiting
OSU6162 as add-on in SSRI/SNRI-resistant Depression
Led by Göteborg University · Updated on 2025-03-24
180
Participants Needed
4
Research Sites
227 weeks
Total Duration
On this page
Sponsors
G
Göteborg University
Lead Sponsor
A
Arvid Carlsson Research AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OSU6162 as add-on in SSRI/SNRI-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participation
- Aged 25 to 65 years on the day of screening
- Diagnosed with major depressive disorder per DSM-5 confirmed by a clinical interview
- Experienced a symptom-free period before the current depressive episode within the past two years
- No significant improvement after at least 6 weeks of treatment with one of these SSRIs/SNRIs: citalopram, escitalopram, paroxetine, sertraline, fluoxetine, duloxetine, or venlafaxine
- A score of 22 or higher on the MADRS depression rating scale
- Women of childbearing potential must have a negative pregnancy test and use effective contraception with less than 1% failure rate during treatment and follow-up
- Male participants must agree to use condoms during the study and for 2 weeks after the last dose unless their partner uses an effective contraception method
You will not qualify if you...
- Current diagnosis of suicidality, manic or hypomanic episodes, bipolar disorders, panic disorder, agoraphobia, PTSD, alcohol or substance abuse/dependency, psychotic disorders, eating disorders, or antisocial personality disorder
- Symptoms of generalized anxiety disorder, OCD, or social anxiety unless mainly due to major depressive disorder
- History of substance or alcohol abuse within 2 years before screening
- Previous diagnosis of personality disorder, autism spectrum disorder, ADHD, or intellectual disability
- Other central nervous system disorders deemed unsuitable for participation
- Any condition or factor that may prevent compliance with treatment or visits
- Any serious physical illness or abnormal lab/ECG findings making participation unsafe
- Changes in SSRI/SNRI dosage within 4 weeks before screening or during the trial
- Use of other psychoactive drugs except limited sleep aids or occasional sedatives within 4 weeks before screening and during the trial
- Treatment with strong cytochrome P450 inhibitors
- Use of drugs with narrow therapeutic windows that require precise dosing
- Previous use of OSU6162
- Current participation in another clinical trial
- Nursing women
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Skåne University Hospital Psychiatry Lund
Lund, Skåne County, Sweden, 222 40
Actively Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Actively Recruiting
3
North Stockholm psychiatry Stockholm region
Stockholm, Sweden, 11321
Not Yet Recruiting
4
Uppsala University Hospital Department of neuroscience
Uppsala, Sweden, 75185
Not Yet Recruiting
Research Team
E
Elias Eriksson, Professor
CONTACT
J
Jakob Näslund, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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