Neuropsychiatric assessment as a secondary outcome measure in a multiple sclerosis intravenous immunoglobulin L(IMg) trial.

Multiple sclerosis (MS) patients often suffer from abnormalities of mood including euphoria, depression, anxiety, pathological laughing and crying (PLC), and psychoses. We assessed neuropsychological functions (NF) as secondary outcome measures in relapsing-remitting multiple sclerosis (RRMS) patients treated by intravenous immunoglobulin (IVIg). Forty RR-MS patients (mean age 34.5±2.4; M : F=8: 32) 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 the Goldberg Anxiety and Depression scales, the Brief Psychiatric Rating Scale, the Hamilton Anxiety Scale, the Beck Depression Inventory, and the Mini-Mental State Examination. Baseline anxiety, depression and general psychopathology scores were similar for the IVIg and placebo groups. At 1 and 2 years, anxiety, depression and general psychopathology had decreased similarly in both groups compared with baseline. No significant cognitive changes were observed in either group. In the IVIg group PLC emerged in one patient and one patient developed clinically overt depression necessitating antidepressant treatment. In the placebo group, two patients developed a hypomanic episode, and PLC emerged in two patients. IVIg treatment is safe, according to psychiatric outcome measures, and these measures should be routinely used in RR-MS drug trials.

RCT Entities:   Population Interventions Outcomes