AuthorisedTherapeutic exploratory (Phase II)Interventional

OSU6162 in Bipolar Depression: An Open-label, Flexible Dose Study (OBID)

Researchers are conducting a study to investigate a new medication, OSU6162, for individuals who have bipolar depression. Bipolar depression is a mental health condition where people experience periods of very low mood. This study is in an early stage (Phase II), meaning it's exploring how well the medication works and if it's safe. Participants will receive OSU6162, and their depressive symptoms will be carefully tracked over about two months using a common mood scale. The main goal is to understand if this new treatment can make a positive difference in managing depression for people living with bipolar disorder.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Of Gothenburg

Enrolment target

Start

28 Oct 2024

Bipolar depression

What is this study about?

This research is focused on helping people who have bipolar depression. Bipolar depression is a condition where individuals experience significant low moods as part of their bipolar disorder. The study is testing a new medication, currently known as OSU6162, to see if it can help improve these depressive symptoms.

The study is called 'open-label,' which means both you and the study doctors will know you are receiving the active medication. It's also 'flexible dose,' meaning the doctors might adjust the amount of medication you take based on how you are feeling and how you are responding to the treatment. This approach allows them to find the right balance for each person involved.

Over roughly two months, the researchers will check in with you several times (on specific days like day 0, 5, 12, 30, 45, and 60) to understand how your mood is changing. They will use a standard tool called the Montgomery-Åsberg Depression Rating Scale (MADRS) to measure any improvements in depressive symptoms. This helps them track the medicine's effects carefully.

Key takeaways

The study is testing a new medicine (OSU6162) for bipolar depression.
It's an early-stage study to see how well the medicine works and if it's safe.
The study lasts about two months, with regular check-ups.
Your mood will be tracked using a special questionnaire.
You must be at least 18 years old and have bipolar depression to join.
You can leave the study at any time.

Who may be eligible?

This study is looking for volunteers who are at least 18 years old. There is no upper age limit, meaning older adults are also welcome to take part. Both men and women can join this study.

To be eligible, you must have a diagnosis of bipolar depression. The study is specifically designed for people experiencing a depressive episode as part of their bipolar disorder.

More specific details about medical history, current medications, or other health conditions would be discussed with the study team to make sure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of bipolar depression?
Are you able to attend appointments over a two-month period?
Are you comfortable knowing you will be taking a study medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, OSU6162, which will be given at a dose of 15 mg. The dose might be adjusted by the study doctors depending on how you respond. The study will last for about two months (60 days), during which you'll have several scheduled visits. These visits are on specific days: Day 0 (when you start), then Day 5, Day 12, Day 30, Day 45, and finally, Day 60.

During these visits, the study team will ask you questions about your mood and how you're feeling. They will use a special questionnaire called the Montgomery-Åsberg Depression Rating Scale (MADRS) to assess your symptoms of depression. This helps them track any changes over time. You'll also have regular check-ups to make sure you're feeling well and to monitor for any side effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A possible benefit of this study is that the new medication, OSU6162, might help improve your symptoms of bipolar depression. However, like all medications, OSU6162 could have side effects, and these would be fully explained to you before you decide to join. It's important to remember that you are a volunteer; you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is OSU6162?

OSU6162 is the name of the new medication being tested in this study for bipolar depression.

How long will I be in the study?

If you join, your participation will last for about two months (60 days).

Will I know if I'm getting the drug or a dummy pill?

In this specific study, both you and the doctors will know you are receiving the active medication, OSU6162.

What kind of visits will I have?

You'll have several scheduled visits over two months, where doctors will check your mood and health.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your usual care.