Study on Adding OSU6162 to Treatment for Patients with Depression Resistant to SSRI/SNRI Medications

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What is this study about?

This clinical trial is focused on studying depression, specifically in patients who have not responded well to certain common antidepressants known as SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors). The treatment being tested is a medication called OSU6162, which is taken as a coated tablet. The purpose of the study is to evaluate how effective and safe it is to add OSU6162 to the ongoing treatment of patients who have not seen significant improvement with their current SSRI or SNRI medication.

Participants in the study will either receive the OSU6162 tablet or a placebo, which looks like the real medication but does not contain the active substance. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of up to 10 weeks, during which the effects of the treatment will be closely monitored.

The main goal is to see if adding OSU6162 can help reduce the symptoms of depression in those who have not responded well to their current medications. The study will measure changes in depression symptoms using a specific scale known as the Hamilton Depression Rating Scale. This trial aims to provide valuable information on whether OSU6162 can be a beneficial addition to existing treatments for depression.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You will need to confirm your age is between 25 and 65 and that you meet the criteria for major depressive disorder as per the DSM-5 guidelines.

2 initial assessment

An initial assessment will be conducted to confirm your current treatment with an SSRI or SNRI medication and that your symptoms have not significantly improved.

A score of 22 or higher on the MADRS (Montgomery-Åsberg Depression Rating Scale) will be required to proceed.

3 medication administration

You will be randomly assigned to receive either the study medication OSU6162 at a dose of 15 mg or a placebo. Both are in the form of a coated tablet.

The medication is taken orally as an add-on to your current SSRI or SNRI treatment.

4 ongoing monitoring

Throughout the study, regular check-ins will be scheduled to monitor your response to the medication and any side effects.

You will be asked to continue using effective contraception methods if applicable, and male participants must agree to use condoms during the study and for two weeks after the last dose.

5 final assessment

At the end of the study, a final assessment will be conducted to evaluate changes in your depression symptoms using the Hamilton Depression Rating Scale.

The results will help determine the effectiveness and safety of adding OSU6162 to your current treatment.

Who Can Join the Study?

Must provide a signed informed consent, which means you agree to participate after understanding the study details.
Must be between the ages of 25 and 65 on the day of screening.
Must have a diagnosis of major depressive disorder confirmed by a specific interview called the Mini International Neuropsychiatric Interview (MINI).
Must have had a period without symptoms before the current episode within the past two years, confirmed during an interview.
Must not have significantly improved after being treated with one of the following medications for at least 6 weeks: citalopram, escitalopram, paroxetine, sertraline, fluoxetine, duloxetine, or venlafaxine. These medications are types of antidepressants known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors).
Must have a score of 22 or higher on a depression rating scale called MADRS (Montgomery-Åsberg Depression Rating Scale).
If you are a woman who can become pregnant, you must have a negative pregnancy test and use a reliable method of birth control during the study and follow-up period. Acceptable methods include hormonal contraception, an intrauterine device (IUD), or other highly effective methods.
Male participants must agree to use condoms during the study and for 2 weeks after the study ends, unless their partner is using a highly effective method of contraception.

Who Cannot Join the Study?

Patients who are not currently taking a medication called a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI) cannot participate. These are types of medications often used to treat depression.
Patients who have not experienced resistance to SSRI or SNRI treatment cannot participate. This means the medication has not been effective in treating their depression.
Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection, such as children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Region Stockholm – SLSO	Stockholm	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Urrcbsq Unyqsdbrhz Hwkrpmyf	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	21.04.2022

Trial locations

Investigated drugs:

OSU6162 is a medication being tested to see if it can help people with depression who have not improved with their current treatment. It is used in addition to the medications they are already taking. The goal is to find out if adding OSU6162 can make their depression better and if it is safe to use.

Selective Serotonin Reuptake Inhibitors (SSRIs) are a type of medication commonly used to treat depression. They work by increasing the levels of serotonin, a chemical in the brain that helps improve mood. In this trial, patients are already taking an SSRI, and the study is testing if adding another medication can help when SSRIs alone are not effective.

Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) are another type of medication used to treat depression. They work by increasing the levels of serotonin and norepinephrine, which are chemicals in the brain that help improve mood and reduce anxiety. In this trial, patients are already taking an SNRI, and the study is testing if adding another medication can help when SNRIs alone are not effective.

Investigated diseases:

Depression

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It often involves changes in sleep, appetite, and energy levels, as well as difficulties in concentration and decision-making. The disorder can lead to emotional and physical problems, affecting a person’s ability to function in daily life. Symptoms can vary in intensity and may occur in episodes that last for weeks or longer. The progression of the disorder can involve recurrent episodes, with periods of remission in between. Over time, the frequency and severity of episodes can change, impacting overall well-being.

Trial ID:

2024-513894-35-00

NCT ID:

NCT05641623

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Adding OSU6162 to Treatment for Patients with Depression Resistant to SSRI/SNRI Medications

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