Actively Recruiting
OSU6162 as add-on in SSRI/SNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety
Led by Göteborg University · Updated on 2025-03-24
180
Participants Needed
4
Research Sites
13 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
Researchers are evaluating OSU6162 as an add-on treatment for adults aged 25 to 65 with major depressive disorder who have not improved after at least 6 weeks of treatment with an SSRI or SNRI. This phase 2, randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of OSU6162 compared to placebo in patients resistant to SSRI/SNRI treatment. The study also explores biomarkers in serum and brain activity changes related to reward processing using fMRI and the Probabilistic Reward Task in optional substudy components. Participants will be randomly assigned to receive either OSU6162 tablets or placebo tablets alongside their ongoing SSRI/SNRI treatment for 6 weeks. OSU6162 is given at flexible doses starting at 15 mg three times daily, with a maximum of 45 mg three times daily. During the treatment period, participants attend seven study visits and have four telephone contacts. Those who respond to treatment based on symptom improvement and a reduction in depression rating scales may continue treatment for an additional 4-week extension phase with three visits and three telephone interviews. Throughout the study, participants undergo various assessments including depression rating scales such as the Bech 6-item subscale of the Hamilton Depression Rating Scale (HDRS) at 42 days, Montgomery Åsberg Depression Rating Scale (MADRS), Clinical Global Impression scales, fatigue and pleasure scales, and serum biomarker measurements. Safety monitoring includes adverse event tracking and laboratory tests. Optional brain imaging with fMRI is performed in substudy participants to assess changes in brain activity. The total participation may last up to 10 weeks for those continuing in the extension phase.
CONDITIONS
Brief Title
OSU6162 as add-on in SSRI/SNRI-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age between 25 and 65 years at screening.
- Diagnosis of major depressive disorder confirmed by a structured interview.
- A symptom-free period before the current episode within the past two years.
- No significant improvement after at least 6 weeks of treatment with specified SSRIs or SNRIs.
- Depression severity with a MADRS score of 22 or higher.
- Women of childbearing potential must have negative pregnancy test and use effective contraception during the study.
- Male participants must agree to use condoms during the study and for 2 weeks after treatment if their partner is of childbearing potential and not using effective contraception.
You will not qualify if you...
- Diagnosis of suicidality, bipolar disorder, panic disorder, PTSD, substance abuse, psychotic disorders, eating disorders, or antisocial personality disorder.
- Generalized anxiety disorder, OCD, or social anxiety unless symptoms are mainly due to depression.
- History of substance or alcohol abuse within 2 years before screening.
- Previous diagnosis of personality disorder, autism spectrum disorder, ADHD, or intellectual disability.
- Other CNS disorders making participation unsuitable.
- Factors likely to prevent compliance with study procedures.
- Significant somatic illnesses or safety concerns including abnormal ECG.
- Change in SSRI/SNRI dose within 4 weeks before screening or during the trial.
- Use of psychoactive drugs other than permitted exceptions within 4 weeks before screening or during the trial.
- Use of potent cytochrome P450 inhibitors.
- Treatment with drugs having narrow therapeutic windows.
- Current treatment with other drugs deemed unsuitable.
- Previous use of OSU6162.
- Participation in another clinical trial.
- Nursing women.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants start treatment with OSU6162 or placebo and attend study visits and phone contacts during the 6-week treatment period.
7 study visits (in-person) and 4 phone contacts
Duration - 4 weeks
Participants responding to treatment may continue in an extension phase with additional visits and phone interviews for 4 weeks.
3 study visits (in-person) and 3 phone contacts
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
J
Jakob Näslund, MD, PhD
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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