DepressionPhase 2ODENNCT05641623
OSU6162 as add-on in SSRI/SNRI-resistant Depression
A Phase 2 study testing OSU6162 in people with Depression and Depressive Disorder, Treatment-Resistant, run by Göteborg University at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder
- What is being tested?
- OSU6162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesSweden
- Study dates
- 21 Apr 2022to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be included in the study, subjects must meet the following criteria:
- 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.
- 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.
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- Displaying a sum score of MADRS ≥22.
- 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:
- Use of combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- Placement of intrauterine device (IUD) or intrauterine hormone releasing system (IUS)
- Bilateral tubal occlusion or ligation
- Vasectomised partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate and provided that male partner is the sole sexual partner of the WOCBP trial participant).
- Sexual abstinence.
- Male patients must agree to use condoms during the study and for 2 weeks after the end of the study/last dose of IMP, unless their partner is using a highly efficient method of contraception, as described above.
Who cannot join
- Subjects must not be included in the study if any of the following criteria are met:
- 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.
- Meeting MINI criteria at interview for generalised anxiety disorder, obsessive compulsive disorder or social anxiety (social phobia), unless the present symptoms can predominantly be attributed to a diagnosis of major depressive 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.
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- Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits, refraining from use of central stimulants etc.
- Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial.
- Any signs or symptoms of somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests, and 12-lead ECG that according to the investigator renders the patient unsuitable for participation for safety reasons, including a QTc-time on ECG exceeding 450 ms in men and 460 ms in women.
- Any change in dosage of said SSRI/SNRI within 4 weeks prior to screening or at any time during the course of the trial.
- Treatment with any other psychoactive drug than said SSRI/SNRI with the exception of using mirtazapine up to 15 mg for sleep, occasional use of benzodiazepines and benzodiazepine-like anxiolytics or hypnotics and occasional use of antihistaminergic sedatives (without anti-dopaminergic effects) within 4 weeks prior to screening and at any time during the course of the trial.
- Patients who are receiving concomitant therapy with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazole, itraconazole, telithromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine).
- Ongoing treatment with drugs with a narrow therapeutic window where either lower or higher serum levels are potentially harmful (including but not limited to warfarin along with other anticoagulants, digoxin along with other antiarrythmics, anticonvulsants prescribed for treatment of epilepsy, cyclosporine, immunosuppressants, and lithium).
- Current treatment with any prescribed or OTC drug that according to the investigator renders the subject unsuitable for participation in the trial.
- Previous intake of OSU6162.
- Current participation in another clinical trial.
- Nursing women.
- Substudy only: Relative and/or absolute contraindications to lumbar puncture and functional Magnetic Resonance Imaging (fMRI), as per clinical practice. This includes ongoing treatment with anticoagulants such as NOAC or warfarin.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
Jakob Näslund, MD, PhD, +46 702 94 79 60, jakob.naslund@pharm.gu.se
Sara Forsmark, Coordinator, +46 703 93 74 43, sara.forsmark@carlssonresearch.eu
- Recruiting
Skåne University Hospital Psychiatry Lund
Lund, Skåne County, 222 40
Daniel Lindqvist, MD, PhD, daniel.lindqvist@med.lu.se
- Not yet recruiting
North Stockholm psychiatry Stockholm region
Stockholm, Stockholm County, 11321
mikael Tiger, PI, MD, PhD, mikael.tiger@ki.se
Johan Lundberg, Co PI, MD, PhD, adj professor, johan.lundberg@ki.se
- Not yet recruiting
Uppsala University Hospital Department of neuroscience
Uppsala, Uppsala County, 75185
Isak Sundberg, PI, MD, isak.sundberg@akademiska.se
Lisa Ekselius, Professor, MD, PhD, lisa.ekselius@neuro.uu.se
About this study
Official title: OSU6162 as add-on in SSRI/SNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety
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).
Read more
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.
Read the detailed description
The treatment period will be 6 weeks during which all subjects will make 7 study visits and be in contact with study nurse or physician by phone at 4 occasions. The first visit is a screening visit followed by a baseline visit for 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 in the extension phase of the study for an additional 4 weeks during which the subjects will make 3 study visits and take 3 telephone interviews.
Before inclusion in the study, all subjects will be informed both verbally and in writing about its purpose, its procedures, and possible risks associated with participation. Before any study-specific procedures take place, written informed consent will be obtained.
Multicenter trial. Multiple sites 4: Sahlgrenska University Hospital Gothenburg, Skåne University Hospital Psychiatry Lund, North Stockholm psychiatry Stockholm region and Uppsala University Hospital Department of neuroscience Uppsala.
For participation in the extension phase, four factors must be fulfilled: 1. The subject must regard himself/herself as clearly improved and be willing to continue. 2. The investigator must assess the subject as clearly improved. 3. The subject must display at least 50% reduction on HDRS6 as compared to baseline. 4. The subject must have signed a new informed consent.
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.
The primary evaluation of efficacy will be undertaken at the endpoint of the 6-week trial. All analyses will however be repeated also at the endpoint of the 4-week extension phase for subjects participating in this part of the study.
Data will be analysed using mixed models for repeated measurement which means that the model includes data from all depression ratings from baseline to endpoint; this method, which is usually recommended to be used in depression trials by the authorities, is considered to handle data loss due to patients leaving a study prematurely in a better way than imputation methods such as the last observation carried forward (LOCF) technique.
- Conditions
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Depressive Episode, Recurrent Depressive Disorder, Recurrent Depression
- Being tested
- OSU6162, Placebo
- Keywords
- Antidepressant, drug therapy, combination, Dopamine Drugs, Dopamine, Selective Serotonin Reuptake Inhibitor, SNRI, SSRI, Serotonin and Norepinephrine Reuptake Inhibitors
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSU6162Drug
Also called OSU-6162, PNU-96391
OSU6162
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| OSU6162 | Active comparator | White, circular, coated tablets. Flexible dosage: the starting dose will be 15 mg TID and the maximal dose 45 mg TID. Receives: Drug: OSU6162 |
| Placebo | Placebo comparator | Coated tablets, flexible dosage, TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endpoint at 42 days treatment
Secondary outcomes (13)
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.
Measured: Endpoint at 42 days treatment
Investigator-rated Montgomery Åsberg Depression Rating Scale (MADRS)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
investigator-rated Clinical Global Impression - Severity scale (CGI-S)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Clinical Global Impression - Change scale (CGI-C)
Investigator rating. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Patient-rated Fatigue Severity Scale (FSS)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Patient-rated MADRS-S (self)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Patient-rated Snaith-Hamilton Pleasure Scale (SHAPS)
Change from baseline with respect to the total score. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Global Rating of Change Scale (GRC)
Patient rating. Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Bech 6-item subscale of the HDRS
Change from baseline with respect to the total score of the investigator-rated Bech 6-item subscale of the HDRS at endpoint in patients displaying a sum rating of ≥36 at the Fatigue Severity Scale at baseline.
Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Patient Global Rating of Change Scale (GRC)
Patient rating of the Global Rating of Change Scale (GRC) at endpoint in patients displaying a sum rating of ≥36 at the Fatigue Severity Scale at baseline.
Lower scores mean a better outcome.
Measured: Endpoint at 42 days treatment
Possible markers of depression
Change from baseline to endpoint with respect to serum levels of a number of possible markers of depression: C-reactive protein (CRP), tumor necrosis factor alpha (TNFα), brain-derived neurotrophic factor (BDNF) and interleukin-6 (IL-6).
Measured: Endpoint at 42 days treatment
AE/SAE
Number of participants with individual AEs and individual SAEs throughout the trial.
Measured: Through study completion
Serum levels of medications
Serum levels of OSU6162 at endpoint and of the prescribed SSRI/SNRI at screening and endpoint.
Measured: Endpoint at 42 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start21 Apr 2022
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Arvid Carlsson Research AB
- Responsible party
- Sponsor
- Investigators
- Elias Eriksson, Professor, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641623
- Sponsor's protocol ID
- EudraCT number: 2020-005860-69
- Other IDs
- 2024-513894-35-00, 2020-005860-69
- Acronym
- ODEN
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSU6162 as add-on in SSRI/SNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05641623
- Acronym / sponsor ID
- ODEN / EudraCT number: 2020-005860-69
- Conditions
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Depressive Episode, Recurrent Depressive Disorder, Recurrent Depression
- Keywords
- Antidepressant, drug therapy, combination, Dopamine Drugs, Dopamine, Selective Serotonin Reuptake Inhibitor, SNRI, SSRI, Serotonin and Norepinephrine Reuptake Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Arvid Carlsson Research AB
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment period will be 6 weeks during which all subjects will make 7 study visits and be in contact with study nurse or physician by phone at 4 occasions. The first visit is a screening visit followed by a baseline visit for 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 in the extension phase of the study for an additional 4 weeks during which the subjects will make 3 study visits and take 3 telephone interviews.
Before inclusion in the study, all subjects will be informed both verbally and in writing about its purpose, its procedures, and possible risks associated with participation. Before any study-specific procedures take place, written informed consent will be obtained.
Multicenter trial. Multiple sites 4: Sahlgrenska University Hospital Gothenburg, Skåne University Hospital Psychiatry Lund, North Stockholm psychiatry Stockholm region and Uppsala University Hospital Department of neuroscience Uppsala.
For participation in the extension phase, four factors must be fulfilled: 1. The subject must regard himself/herself as clearly improved and be willing to continue. 2. The investigator must assess the subject as clearly improved. 3. The subject must display at least 50% reduction on HDRS6 as compared to baseline. 4. The subject must have signed a new informed consent.
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.
The primary evaluation of efficacy will be undertaken at the endpoint of the 6-week trial. All analyses will however be repeated also at the endpoint of the 4-week extension phase for subjects participating in this part of the study.
Data will be analysed using mixed models for repeated measurement which means that the model includes data from all depression ratings from baseline to endpoint; this method, which is usually recommended to be used in depression trials by the authorities, is considered to handle data loss due to patients leaving a study prematurely in a better way than imputation methods such as the last observation carried forward (LOCF) technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind
| Arm | Type | Receives |
|---|---|---|
| OSU6162 | Active comparator | Drug: OSU6162White, circular, coated tablets. Flexible dosage: the starting dose will be 15 mg TID and the maximal dose 45 mg TID. |
| Placebo | Placebo comparator | Drug: PlaceboCoated tablets, flexible dosage, TID |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- 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.
Key exclusion criteria (18 listed)
- 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.
- Meeting MINI criteria at interview for generalised anxiety disorder, obsessive compulsive disorder or social anxiety (social phobia), unless the present symptoms can predominantly be attributed to a diagnosis of major depressive 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSU6162Also: OSU-6162, PNU-96391OSU6162 | Drug | OSU6162 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Bech 6-item subscale of the Hamilton Depression Rating Scale (HDRS)
Time frame: Endpoint at 42 days treatment
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.
13 secondary outcomes
Hamilton Depression Rating Scale (HDRS)
Time frame: Endpoint at 42 days treatment
Investigator-rated Montgomery Åsberg Depression Rating Scale (MADRS)
Time frame: Endpoint at 42 days treatment
investigator-rated Clinical Global Impression - Severity scale (CGI-S)
Time frame: Endpoint at 42 days treatment
Clinical Global Impression - Change scale (CGI-C)
Time frame: Endpoint at 42 days treatment
Patient-rated Fatigue Severity Scale (FSS)
Time frame: Endpoint at 42 days treatment
Patient-rated MADRS-S (self)
Time frame: Endpoint at 42 days treatment
Patient-rated Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Endpoint at 42 days treatment
Global Rating of Change Scale (GRC)
Time frame: Endpoint at 42 days treatment
Bech 6-item subscale of the HDRS
Time frame: Endpoint at 42 days treatment
Patient Global Rating of Change Scale (GRC)
Time frame: Endpoint at 42 days treatment
Possible markers of depression
Time frame: Endpoint at 42 days treatment
AE/SAE
Time frame: Through study completion
Serum levels of medications
Time frame: Endpoint at 42 days treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias Eriksson, Professor study director
Göteborg University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSU6162 in people with Depression and Depressive Disorder, Treatment-Resistant, run by Göteborg University at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elias Eriksson, Professor (+46 709 555055, elias.eriksson@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bech 6-item subscale of the Hamilton Depression Rating Scale (HDRS) (time frame: Endpoint at 42 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.