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New treatment option for Depression
Official title OSU6162 as add-on in SSRI/SNRI-resistant Depression
ClinicalTrials.gov ID: NCT05641623
What this study is testing
What is OSU6162?
OSU6162 is an investigational medicine, being studied as a potential treatment for depression.
Also referred to as OSU-6162, PNU-96391.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- In order to be included in the study, people 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.
You likely can't join if
- people 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...
- 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...
- Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc.
See the full eligibility criteria
- In order to be included in the study, people 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...
- 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...
- 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.
- people 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...
- 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...
- 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...
- Patients who are receiving concomitant therapy with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazole, itraconazole, telithromycin, clarithromycin, protease inhibitors, quinidine, and...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Skåne County, Sweden
- Gothenburg, Västra Götaland County, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Skåne County, Sweden; Gothenburg, Västra Götaland County, Sweden; Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.