Bipolar Depression
Research Study
Bipolar disorder can cause episodes of depression that make daily life very difficult, and current treatments do not work well for everyone. This study is testing a new medication, ALTO-100, to see if it can help adults with bipolar disorder who are currently experiencing a major depressive episode. The study aims to find out whether ALTO-100 is safe and effective compared to a placebo and to learn more about how it may improve symptoms of depression.
Fast Facts
Diagnosed with bipolar I or II disorder
Currently experiencing a moderate-to-severe depressive episode
Compensation
up to $1,200
Conducted in
Austin, TX
Additional Information
This study is being conducted to better understand bipolar disorder with depression and to explore ways to improve treatment options and quality of life for adults experiencing a major depressive episode.
You may be eligible for this study if you meet the following criteria:
Inclusion Criteria:
- Adults aged 18–70 years
- Diagnosed with bipolar I or II disorder and currently experiencing a moderate-to-severe depressive episode
- Taking a stable dose (at least 6 weeks) of a mood stabilizer (e.g., lithium, valproate, lamotrigine) and/or an atypical antipsychotic (e.g., quetiapine, olanzapine, lurasidone, aripiprazole)
Exclusion Criteria:
- Use of certain antidepressants, anticonvulsants (excluding LMG or VPA), or other medications as specified in the study
- Significant medical conditions, recent unplanned hospitalizations, or unstable chronic illnesses
- Prior treatments such as electroconvulsive therapy (ECT), deep-brain stimulation (DBS), vagus nerve stimulation (VNS), or more than two ketamine/esketamine treatments in the current depressive episode
- Significant current PTSD symptoms
Overall Duration:
The study lasts up to 13 weeks. This includes a 6-week placebo-controlled period followed by an optional 7-week study period.
In-Lab Activities:
During visits, you will:
- Complete interviews and questionnaires about mood and daily life
- Take part in neurocognitive tests and rater assessments
- Have blood drawn 5 times
- Complete optional EEGs (2) and EKGs (2)
- Provide a genetic saliva sample
All data collected will be kept private and used only for research purposes.
Please note:
You should ensure you are available for in-person visits every 2 weeks and avoid vacations longer than 2 weeks during the study period.
You will receive $100 for each study visit, for a total of up to $1,200 if all visits are completed. Free parking is provided for all in-person visits. You will also receive your blood work results and can enjoy snacks and water at each visit.
There is no cost for you to participate in our research study.