A new direction in managing Bipolar II Depression
The Bipolar II Depression research study program is investigating the effects of a novel medicine intended to treat adults living with depression (also called a Major Depressive Episode or MDE) associated with bipolar II disorder. This study medicine is being evaluated to see whether it can improve symptoms of depression, including feelings of having less interest or pleasure in the things you used to enjoy (this is called anhedonia, say an-hee-doh-nee-uh)
This medicine is being studied for once-daily use in depression associated with bipolar II disorder and is not currently approved for sale in any country
The Bipolar II Depression study is sponsored by Neumora Therapeutics, Inc.
Bipolar II Depression study participation
You may be able to participate if you:
You may be able to participate if you:
- are 18–65 years old
- have been told by a doctor that you have bipolar II depression without symptoms of psychosis
- have had symptoms of depression for 1–12 months
- use birth control, and are not pregnant or breastfeeding
- can give consent and can follow study instructions
- can participate in 8–10 study visits over 4 months
You may not be able to participate if you:
You may not be able to participate if you:
- have tried more than 1 antidepressant for your current depression
- have been diagnosed with bipolar I disorder, schizophrenia, or psychosis
- had a substance or alcohol use disorder in the last year
- feel suicidal or at serious risk of ending your life
- have other specific health conditions that may impact your ability to participate
- if you test positive for THC or other substances
Challenges in living with bipolar II depression
- Depression is common among people living with bipolar II disorder1
- Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) are the most commonly prescribed antidepressant medications2 However, these medications do not manage depression successfully in all people, and are used in people with bipolar disorder despite only low or very low-quality evidence supporting their efficacy3
- Second-generation antipsychotic agents are now the agents prescribed most frequently for patients with bipolar disorder.4 However, in one study, less than one-half of the people with bipolar I or II treated with a second-generation antipsychotic achieved remission of symptoms of depression5
- People treated for depression with currently approved antidepressants often experience side effects, such as weight gain, sexual problems, stomach/digestive issues, and lack of emotions, which can mean they do not take their medications as prescribed by their doctors6-9
- Current medications do not fully treat anhedonia (inability to experience pleasure or enjoyment from activities that would normally be pleasurable), which occurs in as many as 90% of patients with bipolar depression10-11
About the study medicine
This once-daily medicine was created to work in a new way on specific pathways in your brain that affect key symptoms of depression, including the feelings of having less interest or pleasure in the things you used to enjoy. This is a new approach that works differently than SSRIs or SNRIs. The study medicine will be compared to placebo to evaluate its safety and efficacy. Half of participants will receive the once-daily study medicine and half will receive the placebo pill
About the Bipolar II Depression study
What to expect in the Bipolar II Depression study
The Bipolar II Depression study is evaluating the potential efficacy and safety of the study medicine in about 60 people with depression associated with bipolar II disorder. You will receive treatment from your study doctor and can continue to receive care from the doctor who usually treats your depression
There are 3 parts to the study:
A screening period of up to 28 days
A 6-week treatment period
A 6-week safety follow-up period
Part 1
Screening period
Timing: up to 28 days
- You will visit the study doctor’s office, where the study doctor will talk to you and run tests to determine whether you can be in the study
- This may take 1–2 visits for about 3–4 hours each
- The study doctor will use questionnaires to understand your symptoms of depression
- You may need to make further office visits during this period, as determined by your study team
Part 2
Treatment period
Timing: 6 weeks
- Both the study medicine and placebo pill are once-daily, and you will not know which type of pill you are receiving
Study medicine
- Your doctor will explain how to record each pill you take, so no doses are missed
- During the study, you will visit the clinic 5 times, when study doctors will ask about your symptoms of depression using questionnaires, and note any side effects
- If you stop treatment, you will have a final follow-up visit with the study doctor
Part 3
Safety follow-up period
Timing: 6 weeks
- After your last pill, you will have 2 additional clinic visits
Where would I go to participate?
The Bipolar II Depression study will take place at locations across the US. Complete the CHECKLIST to see if the Bipolar II Depression study is right for you. Visit clinicaltrials.gov for more information on study site locations.
During the Bipolar II Depression study, you will receive all study-related medical care from a dedicated team at no cost. Reimbursement for study-related expenses may be available to you
Questions about taking part in a clinical study
What is a clinical study?
Clinical studies are essential to determine whether new, investigational treatments are safe and effective for use in patients. When you agree to take part in a clinical study, you may help doctors determine the efficacy and safety of a new treatment for a specific disease. Clinical studies rely on people with a specific disease to help researchers develop new treatments for people that need them
What support is available to me during a clinical study?
There are rules in place to make sure that the rights, well-being, and privacy of people entering a clinical study are respected. During the study, support is available to provide help and information about the Bipolar II Depression study
Why should I participate?
There are lots of reasons for taking part in a clinical study. It can give you access to new, investigational treatments, and involve you in the development of therapies that may benefit others. Deciding to participate is a personal decision – get in touch if you think it might be right for you!
What if I change my mind about taking part?
If you decide to participate in the study, you can change your mind and decide to leave the study at any time, whatever the reason
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The National Alliance on Mental Illness (NAMI) is the nation’s largest grassroots mental health organization dedicated to improving the lives of individuals and families affected by mental illness. NAMI provides advocacy, education, support, and public awareness so that all individuals and families affected by mental illness can build better lives.
Depression and Bipolar Support Alliance (DBSA) offers hundreds of local and online support groups, including identity-focused groups and support for parents and caregivers. DBSA has readily understandable information about depression and bipolar disorder and empowering tools focused on an integrated approach to wellness.
The Bipolar II Depression study is evaluating the potential efficacy and safety of the study medicine in about 60 people with depression associated with bipolar II disorder.
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1. Judd LL, et al. Arch Gen Psychiatry. 2003;60(3):261-269.
2. Luo Y, et al. Front Psychiatry. 2020;11:35. 3. Fellendorf FT, et al. Pharmaceuticals (Basel). 2023 Jan 25;16(2):182.
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5. Köhler-Forsberg O, et al. Psychiatry Res. 2021;305:114194.
6. Kemp DE. J Affect Disord. 2014;169 Suppl 1:S34-S44.
7. Bai Y, Chen G, Yang H, Gao K. J Affect Disord. 2020;261:259-270.
8. Thomas K, Saadabadi A. Olanzapine. In: StatPearls. Treasure Island (FL): StatPearls Publishing; August 28, 2023.
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10. Wilkowska A, et al. Bipolar Disord. 2024;26(4):356-363.
11. Serretti A. Clin Psychopharmacol Neurosci. 2023;21(3):401-409.