Mid-study report on the CAN-BIND-1 study for personalizing depression treatment
Original article title: Discovering biomarkers for antidepressant response: CAN-BIND protocol and clinical characteristics of the first patient cohort
What is this research article about?
This paper provides an overview of a clinical study called CAN-BIND-1. The CAN-BIND-1 study aims to find biological characteristics called “biomarkers” that can predict how an individual will respond to a certain antidepressant drug treatment. The research findings may lead to more personalized treatment approaches for depression. There are currently no objective measures to guide treatment selection, so the time it takes to find effective treatment for depression can be extensive. Biomarkers could be used to quickly identify the “right” treatment for each person.
This paper describes the research methods used in the CAN-BIND-1 study, and provides information about the study participants, such as average age and the ratio between sexes. This information can help readers understand how applicable the results of the study are to other populations.
What happened in this research study?
CAN-BIND researchers recruited study participants across six hospitals in Canada, and the same study protocol was used at each hospital. By standardizing the study protocol, the researchers will be able to combine the data collected from all six hospitals into one dataset. The standardized dataset will allow the researchers to use complex mathematical analysis to better understand depression and gain insight to why some people respond to antidepressant drugs while others do not.
The study takes place over 16 weeks and includes two groups: (1) patients with a diagnosis of major depression; and (2) comparison participants (i.e. participants who do not have depression, but are otherwise similar to the patient group). All participants complete baseline testing at the start of the study. They are tested again at various time points throughout the 16 weeks, so that comparisons can be made to the baseline measurements. The study includes clinical questionnaires to measure participants’ mood, behavior and experiences. The researchers also take brain scans, measure electrical recordings of brain activity, and take blood samples for lab analyses.
At the start of the study, all patients with depression are prescribed an antidepressant called escitalopram (also known by the brand names Cipralex, Lexapro, and others), with flexible dosing of 10-20 mg/day. They remain on this drug until week 8, at which point they are assessed again using the same tests, brain scans, and blood work as at the beginning of the study. If the patient’s depression symptoms improve by 50% (as assessed by the study doctors using a standard rating scale), they are classified as “responders” and stay on their initial escitalopram treatment for the remaining 8 weeks of the study. If they do not respond, they are classified as “non-responders”, and an additional drug called aripiprazole (also known by the brand name Abilify) is added to their treatment at a dose of 2-10 mg/day for the rest of the study. Treatment response is evaluated again at the end of the study.
Information collected from the study participants is “de-identified”, meaning any names or identifying factors are removed to protect the privacy of the patient. The de-identified information is uploaded into a data management platform called Brain-CODE, which allows researchers to collaboratively analyze the data to find relationships between the study groups and to find trends of treatment response.
What were the main findings?
This paper describes the methods used in the CAN-BIND-1 study and characteristics of the first group of 134 participants. The study was ongoing at the time this paper was published, with the aim of recruiting a total of 290 participants. This paper does not contain results of the clinical study.
Some of the characteristics of the first study group include:
- The average age of the 85 patients with depression was 36, while the average age of the 49 comparison group participants who did not have depression was around 32;
- There were more female patients with depression (59%) than male (41%).
This paper describes an ongoing study that aims to identify biomarkers of depression treatment response, in order to connect individuals with a personalized treatment that works. By guiding personalized treatment selection, such biomarkers may improve treatment practice and clinical outcomes.
The original research article was written by RW Lam, R Milev, S Rotzinger and colleagues and published in BMC Psychiatry in 2016.
Full reference for the original research article:
Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews M, Minuzzi L, Müller DM, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry 2016;16:105.
Lay summary author: Clare Lambert (CAN-BIND Trainee)
Contributing editors: CAN-BIND CAC Members including Shelley Flam, Darien Landreth and Kathryn Schade and CAN-BIND Staff including Aleksandra Lalovic, Janice Pong and Julie Stinson