NIHR Clinical Research Facility: Oxford Health, in partnership with ALTO Neuroscience is recruiting for a new study. The ALTO-100-211 research study is exploring a potential new treatment for people living with bipolar depression who are currently experiencing symptoms despite ongoing treatment.
What is the ALTO-100-211 study?
The purpose of the research study is to compare the effects of ALTO-100, the study’s investigational drug, versus placebo (an inactive substance) in treating symptoms of bipolar depression (BD) in participants who have BD with depression (BD-D) and who are also taking mood stabilizers and/or an atypical antipsychotic.
What is bipolar depression?
Bipolar depression is diagnosed based on a history of mania or hypomania and the presence of a current major depressive episode. Symptoms can impair your functioning at work or school, your social and personal relationships and other important aspects of your life.
Am I eligible?
If you’re living with bipolar depression, you may be eligible for the ALTO-100-211 study.
The ALTO-100-211 study is looking for adults who:*
- Are 18-70 years old
- Have an existing diagnosis of bipolar disorder with depression (BD-I or BD-II) and are currently depressed
- At baseline, taking a mood stabilizer and/or one approved atypical antipsychotic for at least six weeks with no dose modifications in the past 2 weeks
- Are willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding
If you meet these criteria, the ALTO-100-211 study may be of interest to you.
*Additional criteria may apply.
How long will the study last?
The study will last approximately three to four months, consisting of a screening period (about six weeks), followed by a six-week double-blind treatment period where you may receive ALTO-100 or placebo. If you complete the double-blind treatment period, you will be given the option to enter an open-label period where you are guaranteed to receive ALTO-100. Eligible participants will receive study-related care and evaluations at no cost. Compensation for your time and travel may be available.
Importantly, as a study participant you will remain under the care of your current doctor while also working with a team of research doctors and study staff who will monitor your overall health while participating in the trial. You will work with a current doctor to ensure information is shared with them if that is their preference and you will continue under the care of your current doctor after completing the trial.
Contact us to learn more or to sign up to the study
Email: [email protected]. Please include “ALTO 100 study” in the subject title.
Telephone: 01865 902 135 and ask to speak to someone about the ALTO 100 study.
