Sequential Multiple Assignment Randomized Trial for Bipolar Depression

This study is looking for adults aged between 18 and 75 years old. To join, you must have been diagnosed with Bipolar I or Bipolar II disorder and currently be experiencing a depressive episode that has lasted for at least two weeks. You should also be able to be looked after as an outpatient, meaning you don't need to stay in a hospital for your care, and be willing to try one of the study treatments at random.

There are also some reasons why you might not be able to join. For example, if you are currently having a manic episode, or if your mood changes very quickly (four or more times a year). People with a history of schizophrenia or other types of psychosis, or those with current serious substance use issues that would affect their ability to take part, cannot join. If you're pregnant or breastfeeding, you also wouldn't be able to participate. Also, if you've had a bad reaction to any of the study medications before, or if a doctor determined that taking the study medications would not be clinically good for you, you won't be able to participate.

If you decide to take part, you'll be randomly assigned to one of the four study treatments. This is similar to drawing names out of a hat. You'll have regular check-ups and assessments to monitor how you're feeling and how the treatment is working. These appointments will involve answering questions and potentially some other simple tests.

If the first treatment you receive doesn't fully help with your depression after about 6 weeks, you might be given the option to try a different study treatment, again chosen at random from the remaining options. All participants will be followed for a full year (52 weeks) from the start of the study. This helps the researchers understand the long-term effects of the treatments and how they help people stay well.