Trends in Neuropsychiatric Terminology Use Within Registered Clinical Trials for Multiple Sclerosis: A Retrospective...

Area of Science:

• Neurology
• Clinical Trials Research
• Psychiatry

Background:

• Multiple sclerosis (MS) patients frequently experience neuropsychiatric (NP) conditions, impacting quality of life.
• Clinical trials are crucial for developing effective management strategies for these NP conditions in people with MS (pwMS).

Purpose of the Study:

• To analyze temporal trends in the inclusion of NP terms within MS clinical trials.
• To identify potential research gaps concerning NP comorbidity in MS.

Main Methods:

• A Python-based program analyzed NP terms (fatigue, depression, pain, anxiety) in MS clinical trials registered on clinicaltrials.gov (2000-2024).
• Temporal trends were assessed by correlating NP term mentions with trial start years.
• Multivariable logistic regression examined associations between trial factors and NP term inclusion.

Main Results:

• Of 2674 trials, 15.3% included at least one NP term: fatigue (293), depression (115), pain (98), anxiety (49).
• The inclusion of fatigue, depression, and anxiety terms increased over time.
• Each year increase in trial start was associated with a 6% rise in NP term inclusion odds; industry funding decreased these odds by 72%.

Conclusions:

• There is a growing trend to incorporate NP comorbidity considerations in MS clinical trials.
• Industry-funded trials show a lower likelihood of including NP considerations, indicating a potential gap in research design and funding allocation.