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A Study of OSU6162 in Adults with Bipolar Depression to Evaluate Safety and Effectiveness

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on patients with Bipolar Depression, a mental health condition characterized by episodes of depression in people with bipolar disorder. The study will test a medication called OSU6162, which is a dopamine stabilizer, given in the form of coated tablets taken by mouth. The purpose is to evaluate how well this medication works and how well patients tolerate it when used to treat bipolar depression.

During the study, participants will take OSU6162 tablets daily for up to 8 weeks while continuing their current mood stabilizer medication. The maximum daily dose of the study medication will be 135 mg. Patients will need to stay in a psychiatric ward during the study period. The medication will be given in flexible doses, which means the amount can be adjusted based on individual patient response.

Throughout the study period, healthcare providers will monitor patients' depression symptoms using standardized rating scales. They will track any changes in depression severity and observe how participants respond to the treatment. Regular check-ups will be conducted to ensure patient safety and to evaluate the medication's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your eligibility for the study will be confirmed through a psychiatric evaluation using the Mini International Neuropsychiatric Interview (MINI)
A depression assessment will be performed using the Bech 6-item subscale of the Hamilton Depression rating Scale
You need to be on a stable dose of mood stabilizer for at least 4 weeks before starting the study
Step 2
Starting medication
You will receive OSU6162 in the form of 15 mg coated tablets
The medication needs to be taken by mouth
You will continue taking your current mood stabilizer throughout the study
Step 3
Regular evaluations
Your depression symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS)
Evaluations will take place on the following days: day 0 (start), day 5, day 12, day 30, day 45, and day 60
The total duration of your participation will be 60 days
Step 4
Safety requirements
If you are a woman who can become pregnant, you must use highly effective birth control throughout the study
If you are a male participant, you must use condoms during the study and for 2 weeks after the last dose
Regular safety assessments will be conducted throughout your participation
Step 5
Study completion
A final evaluation will be conducted on day 60
Your participation in the study will end after the final assessment

Who can join the trial?

13 criteria

Must sign an informed consent form to participate in the study
Must be willing to be admitted to a psychiatric ward at or after screening
Age must be between 18 and 65 years at screening
Must have a diagnosis of Bipolar Disorder type I or II with current depressive episode, confirmed by a special psychiatric interview (MINI)
Must score 10 or higher on the Bech 6-item depression rating scale
check
Must be taking a stable dose of one of these mood stabilizers for at least 4 weeks before screening:
- Lithium (blood level above 0.45 mmol/L)
- Lamotrigine (dose of 100 mg or more per day)
- Valproate (dose of 900 mg or more per day)
- Carbamazepine (blood level of 20 mmol/L or higher)
- check
  For women who can become pregnant:
  - Must have a negative pregnancy test
  - Must use highly effective birth control (such as implants, injections, certain IUDs, or partner's sterilization)
  - For male participants:
    
    Must use condoms during the study and for 2 weeks after
    This requirement does not apply if partner uses highly effective birth control

Who cannot join the trial?

12 criteria

Current diagnosis of any psychiatric disorder other than bipolar depression
History of substance abuse or dependence within the past 6 months
Significant risk of suicide or self-harm
Pregnant women or women who are breastfeeding
Use of any other investigational drug within 30 days before screening
Serious or unstable medical conditions that could interfere with the study
History of seizures or other neurological disorders
Abnormal laboratory test results that are clinically significant
Current use of medications that could interact with the study drug
Unable to provide informed consent
History of non-response to similar treatments
Any condition that, in the investigator's opinion, makes the patient unsuitable for the study

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Verified sites

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Sahlgrenska University Hospital
Gothenburg, Sweden

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Investigated drugs

OSU6162 is an experimental medication being studied for treating depression in people with bipolar disorder. It belongs to a class of drugs that work by regulating dopamine, a chemical messenger in the brain that affects mood. This medication aims to help stabilize mood and reduce depressive symptoms in patients with bipolar disorder. The drug is still in research phase and is currently known by its code name as it hasn't received an official generic name yet.

3-(3-Methanesulfonyl-Phenyl)-1-Propyl-Piperidine Hydrochloride

What is already known about the treatment

OSU6162 - An investigational drug administered orally that acts as a monoaminergic stabilizer, specifically developed for treating bipolar depression. This compound works by modulating dopamine and serotonin systems in the brain, helping to stabilize mood fluctuations characteristic of bipolar disorder. Currently undergoing clinical trials to evaluate its efficacy and safety, OSU6162 represents a novel approach in psychopharmacology with its unique mechanism of action that aims to normalize rather than simply increase or decrease neurotransmitter activity. The medication belongs to the class of dopamine stabilizers and is being studied as a potential treatment option for patients with bipolar depression, where current therapeutic options may be limited or insufficient.

Investigated diseases

Bipolar Depression - A mental health condition that represents the depressive phase of bipolar disorder, characterized by persistent feelings of sadness, hopelessness, and loss of interest in activities. During this phase, individuals typically experience low energy levels, changes in sleep patterns, and difficulty concentrating. The condition involves episodes that can last for weeks or months, during which a person may also experience changes in appetite, reduced physical activity, and social withdrawal. Bipolar depression alternates with periods of normal mood, and in some cases, with episodes of mania or hypomania. The symptoms tend to develop gradually and can vary in intensity over time.