TeriMOOD Study Design: Assessing Changes in Depressed Mood in Patients with RMS Switching from IFNB to Teriflunomide Due to Symptoms of Depression

Thursday, June 2, 2016
Exhibit Hall
Lori Hendin Travis, MD , Phoenix Neurological Associates Ltd, Phoenix, AZ
Jeffrey Chavin, MD , Genzyme, a Sanofi company, Cambridge, MA
Maria Melanson, MD, PhD , Genzyme, a Sanofi company, Cambridge, MA
Adel Gehchan, MD , Genzyme Canada, Mississauga, ON, Canada
Matt Mandel, MD , Genzyme, a Sanofi company, Cambridge, MA


Teriflunomide is an immunomodulatory agent approved for the treatment of relapsing forms of MS (RMS). Depression is a common symptom in patients with MS, with lifetime prevalence estimates as high as 50%. Depression is a result of both neuropathology (eg, brain lesions) and psychosocial factors (eg, coping style, a social support system). There is also evidence that some MS treatments, such as interferon B (IFNB), may exacerbate depression. It is important to address depression in patients with MS, as this comorbidity can lead to reduced health-related quality of life (QoL), reduced adherence to therapy, and increased morbidity and mortality.


To describe the design of the TeriMOOD study, which evaluates changes in depressed mood in patients with RMS switching from IFNB therapy to teriflunomide due to symptoms of depression.


TeriMOOD is a prospective, multicenter, single-arm observational study being initiated in the United States and Canada. Inclusion criteria: patients aged 18–65 years (inclusive), a diagnosis of RMS, switching from any IFNB therapy (prior duration of treatment ≥6 months) to teriflunomide 14 mg due to symptoms of depression, and a screening Beck Depression Inventory II (BDI-II) score ≥14. Target recruitment is 75 patients. The primary endpoint is the assessment of changes in depressed mood over 6 months, as measured by BDI-II. Secondary endpoints include the proportion of patients who remain free of relapse after 6 months, changes in health-related QoL (measured using the Multiple Sclerosis International Quality of Life [MusiQoL] scale), and cognitive function (measured using the Symbol Digit Modalities Test [SDMT]). The tertiary endpoint is change in antidepressant use. Adverse events are monitored throughout the study.


BDI-II, MusiQoL, and SDMT assessments used in TeriMOOD will be discussed in more detail in the presentation. Patient results from TeriMOOD will be reported after study completion.


TeriMOOD will evaluate the impact on QoL and cognitive function when switching treatment from IFNB to teriflunomide due to the presence of depressed mood. Understanding depressive mood changes and their impact on QoL is an important area of research, particularly given the recent trend to prioritize wellness and emotional well-being in treatment goals for patients with MS.