Virtual Clinical Trials in Depression

Mental health is a major public health issue. Depression in particular faces an important unmet need. Diagnosis often takes 10 years or more to be established. Almost all the treatments available are based on the same mechanism of action. The future for this disease lies in 1) early diagnosis and 2) identification of the best treatment for each sufferer. Healint paves the way to precision medicine by providing tools and data that will allow to reach these 2 objectives.

Our goal remains to help patients. One of the ways to achieve this is to accelerate the reach of new treatments on the market. Healint conducts Phase 2 and phase 3 clinical trials, in compliance with Good Clinical Practices, for submission to authorities.

Participants to clinical trials find stressful the visits to the site. Living more than 2 hours away from the closest site is a major hurdle for participation. Having to take half a day, or sometimes a full day for the site visit is a sacrifice that many patients are not ready to make just to participate in a study. Virtual clinical trials conducted by Healint, solve all these issues at once.

We run all the most popular scales for Depression trials. Thanks to our flexible and versatile e-COA collection tool, we are also able to use any scale of interest in this therapeutic area. In parallel, our R&D also develops a new scale more adapted to the current way of conducting trials, that is more patient-oriented and also sensitive to treatment efficacy. Our methodology is also innovative as we propose a central double evaluation of the patients. This reduces site-induced bias by increasing homogeneity in rating.

MADRS

(ClinRO)

The Montgomery–Åsberg Depression Rating Scale is a ten-item diagnostic questionnaire used by clinicians to measure the severity of depressive episodes in patients with mood disorders. It is designed to be sensitive to change resulting from antidepressant therapy. As such, it is the most widely used scale, as the primary endpoint in clinical trials. 

MADRS-S

(PRO)

This is a self-reported version of the MARDS. Developed by the same authors as the original version. So far never used in clinical trials for new treatment under development, it is however properly validated as a complementary tool to the classical version, but could also be used as a stand alone measure.

BDI

(PRO)

Less frequently used than MARDS in pharma-sponsored trials, the Beck Depression Inventory is widely used by academic researchers. It is a 21-question multiple choice self-report inventory. The BDI was originally developed to provide a quantitative assessment of the intensity of depression. Because it is designed to reflect the depth of depression, it can monitor changes over time and provide an objective measure for judging improvement and the effectiveness of treatment methods.

HAM-D

(ClinRO)

Hamilton Scale of depression is widely used in academic research, and less often as a primary endpoint in antidepressant trials, as it is less sensitive to treatment than other scales. HAM-D is a 17 item questionnaire completed by a clinician during an interview with the patient.

PHQ-9

(PRO)

The Patient-Health Questionnaire is the depression module of the self-administered version of PRIME-MD diagnostic instrument for common mental disorders. It is a tool used to monitor the severity of depression and response to treatment. It is not a screening tool, but the 2 question version, PHQ-2 can be used for this purpose.