Neuropsychiatrie assessment as a secondary outcome measure in a multiple sclerosis IVIg trial

Objective To assess neuropsychological functions (NF) in relapsing-remitting multiple sclerosis (RR-MS) patients treated by IVIg as secondary outcome measures. Background It is recognized that mental changes are common in MS. Abnormalities of mood including euphoria, depression, anxiety, pathological laughing and crying (PLC), and psychosis often exist in MS. With the recent advent of new drugs for RR-MS, a debate as to which outcome measures are to be used in Phase II/III trials emerged. NF affects quality of life and rehabilitation efforts and thus is a probable outcome measure. Methods: Forty RR-MS patients (mean age 34.5±2.4, 32 females) were randomized to receive either IVIg or placebo in a double-blind trial for 2 years. NF evaluation at baseline, 1 and 2 years, included Goldberg Anxiety and Depression Scales, Brief Psychiatric Rating Scale, Hamilton Anxiety, and the Beck Depression Inventory. Results Baseline anxiety, depression and general psychopathology scores were similar for the IVIg and placebo groups. At 1 year and 2 years anxiety, depression and general psychopathology decreased similarly in both groups compared with baseline. In the IVIg group in 1 patient PLC emerged. In the placebo group 2 patients developed hypomanic episodes, in 2 patients PLC emerged and 1 patient developed clinically severe depression necessitating anti-depressant treatment. Conclusions IVIg treatment is safe in regard to psychiatric outcome measures and these measures should be routinely used in RR-MS drug trials.