Depression Clinical Trial
— ODENOfficial 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. 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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | August 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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 containing) hormonal contraception associated with inhibition of ovulation - oral - intravaginal - transdermal 2. progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable 3. Placement of intrauterine device (IUD) or intrauterine hormone releasing system (IUS) 4. Bilateral tubal occlusion or ligation 5. 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). 6. Sexual abstinence. 8. 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. Exclusion criteria Subjects must not be included in the study if any of the following criteria are met: 1. 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. 2. A history of substance/alcohol abuse within 2 years prior to screening. 3. A previous diagnosis of a personality disorder, autism spectrum disorder, attention-deficit/hyperactivity disorder, or intellectual disability. 4. Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial. 5. Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc. 6. Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial. 7. 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. 8. Any change in dosage of said SSRI/SNRI within 4 weeks prior to screening or at any time during the course of the trial. 9. 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. 10. 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). 11. 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). 12. Current treatment with any prescribed or OTC drug that according to the investigator renders the subject unsuitable for participation in the trial. 13. Previous intake of OSU6162. 14. Current participation in another clinical trial. 15. Nursing women. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | Västra Götaland |
Sweden | Skåne University Hospital Psychiatry Lund | Lund | Skåne |
Sweden | Karolinska Institutet Clinical Neuroscience | Stockholm | |
Sweden | Uppsala University Hospital Department of neuroscience | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Arvid Carlsson Research AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Endpoint at 42 days treatment | |
Secondary | 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. |
Endpoint at 42 days treatment | |
Secondary | Investigator-rated Montgomery Åsberg Depression Rating Scale (MADRS) | Change from baseline with respect to the total score. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | investigator-rated Clinical Global Impression - Severity scale (CGI-S) | Change from baseline with respect to the total score. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | Clinical Global Impression - Change scale (CGI-C) | Investigator rating. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | Patient-rated Fatigue Severity Scale (FSS) | Change from baseline with respect to the total score. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | Patient-rated MADRS-S (self) | Change from baseline with respect to the total score. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | Patient-rated Snaith-Hamilton Pleasure Scale (SHAPS) | Change from baseline with respect to the total score. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | Global Rating of Change Scale (GRC) | Patient rating. Lower scores mean a better outcome. | Endpoint at 42 days treatment | |
Secondary | 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. |
Endpoint at 42 days treatment | |
Secondary | 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. |
Endpoint at 42 days treatment | |
Secondary | 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 (TNFa), brain-derived neurotrophic factor (BDNF) and interleukin-6 (IL-6). | Endpoint at 42 days treatment | |
Secondary | AE/SAE | Number of participants with individual AEs and individual SAEs throughout the trial. | Through study completion | |
Secondary | Serum levels of medications | Serum levels of OSU6162 at endpoint and of the prescribed SSRI/SNRI at screening and endpoint. | Endpoint at 42 days treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |