OSU6162 as add-on in SSRI/SNRI-resistant depression (ODEN): a double-blind, placebo-controlled evaluation of efficacy and safety

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Gothenburg

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04], Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513894-35-00

EudraCT number

2020-005860-69

ClinicalTrials.gov

NCT05641623

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Dose response, Safety

To assess the effect and tolerability of adding OSU6162 to ongoing treatment with a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI) in patients with SSRI/SNRI-resistant depression.

Conditions and MedDRA coding

Depression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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: a) Use of combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral - intravaginal - transdermal b) progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable c) Placement of intrauterine device (IUD) or intrauterine hormone releasing system (IUS) d) Bilateral tubal occlusion or ligation e) 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). f) 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 1

1. 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, ketoconazol, itraconazole, telitromycin, 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. 16. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 (10).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Gothenburg

Sponsor organisation

University Of Gothenburg

Address

P. O. Box 100

City

Gothenburg

Postcode

405 30

Country

Sweden

Scientific contact point

Organisation

University Of Gothenburg

Contact name

Elias Eriksson

Public contact point

Organisation

University Of Gothenburg

Contact name

Elias Eriksson

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications