Take part in Bipolar Depression research (ALTO-100 study)

young woman sitting and talking to her psychologist during a consultation

Study overview

This study is looking at how well a new type of medication, ALTO‑100, works compared to a placebo (a pill with no active ingredients) for treating symptoms of depression in participants who have Bipolar Disorder with depression (BD-D). The participants are also taking mood stabilizers and/or an atypical (second generation) antipsychotic medication.

Participating in the trial

The study takes place at King’s College Hospital, lasts about 3–4 months and includes 3 parts:

  1. Screening period (about 6 weeks): The study team checks your health and makes sure the study is a good fit for you.
  2. Double‑blind treatment period (6 weeks): You will receive either the ALTO‑100 medication or a placebo, but neither you nor the study team will know which one you’re taking during this phase.
  3. Optional open‑label period (7 weeks): If you finish the double‑blind phase, you can choose to continue in a phase where everyone receives ALTO‑100.

Importantly, study participants will remain under the care of their 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 your 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.

What compensation is available?

Eligible participants will receive study-related care and evaluations at no cost.

Compensation for your time and travel may be available:

  • £25 for Visits 4, 5, 6, 8, 9, 10, and 12.
  • £60 for Visits 1, 2, 3, 7, and 11.

What is Bipolar Depression and am I eligible?

Bipolar depression is a mental health condition where you have extreme mood changes. It is a diagnosis 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.

Eligibility criteria

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 medication for at least 6 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 eligibility criteria apply

How do find out more about taking part? 

For more information, please contact Deborah Reyes, Clinical Trial Coordinator, at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London.

Email: deborah.1.reyes@kcl.ac.uk