OSU6162 as add-on in SSRI/SNRI-resistant Depression

NCT05641623 | Recruiting Phase 2 DMC

• 3 other identifiers: EudraCT number: 2020-005860-692024-513894-35-002020-005860-69
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Hamilton Depression Rating Scale (HDRS)

  Endpoint at 42 days treatment

• Investigator-rated Montgomery Åsberg Depression Rating Scale (MADRS)

  Endpoint at 42 days treatment

• investigator-rated Clinical Global Impression - Severity scale (CGI-S)

  Endpoint at 42 days treatment

• Clinical Global Impression - Change scale (CGI-C)

  Endpoint at 42 days treatment

• Patient-rated Fatigue Severity Scale (FSS)

  Endpoint at 42 days treatment

Study Arms (2)

OSU6162

ACTIVE COMPARATOR

White, circular, coated tablets. Flexible dosage: the starting dose will be 15 mg TID and the maximal dose 45 mg TID.

Drug: OSU6162

Placebo

PLACEBO COMPARATOR

Coated tablets, flexible dosage, TID

Drug: Placebo

Interventions

OSU6162 DRUG

OSU6162

Also known as: OSU-6162, PNU-96391

OSU6162

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be included in the study, subjects must meet the following criteria:
• Signed informed consent.
• Age: 25-65 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.
• 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

You may not qualify if:

• 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.
• Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits 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.

Sponsors & Collaborators

• Göteborg University: lead
• Arvid Carlsson Research AB: collaborator

Study Sites (4)

Skåne University Hospital Psychiatry Lund

Lund, Skåne County, 222 40, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

North Stockholm psychiatry Stockholm region

Stockholm, 11321, Sweden

NOT YET RECRUITING

Uppsala University Hospital Department of neuroscience

Uppsala, 75185, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant; Depressive Disorder

Interventions

OSU 6162; 3-(3-(methylsulfonyl)phenyl)-1-propylpiperidine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Elias Eriksson, Professor

  Göteborg University

  STUDY DIRECTOR

Central Study Contacts

Elias Eriksson, Professor

CONTACT

+46 709 555055; elias.eriksson@neuro.gu.se

Jakob Näslund, MD, PhD

CONTACT

+46 702 947960; jakob.naslund@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Monitor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 7, 2022
• Study Start: April 21, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)