Report of two double-blind randomized placebo-controlled pilot studies of a carbohydrate-rich nutrient mixture for treatment of seasonal affective disorder (SAD).

We investigated a carbohydrate-rich nutrient-drink mix for treatment of seasonal affective disorder (SAD). This mixture may contribute to brain serotonin synthesis, potentially exerting an antidepressant effect and controlling carbohydrate cravings. Two successive double-blind placebo-controlled studies were performed. In Study 1, 18 subjects (50% women; mean age 43 +/- 15 years) with SCID-diagnosed SAD were randomized to 12 days of twice daily carbohydrate beverage (CHO) containing mixed starches, or a placebo beverage (PRO) containing the CHO mix plus casein protein to dampen serotonin synthesis. Following a 2-day washout, subjects were crossed over to the other treatment for 12 days. In Study 2, 32 subjects (63% women; mean age 46 +/- 14 years) with SCID-diagnosed SAD were randomized to 21 days of CHO or PRO. Efficacy in both studies was determined by the first 17 items of the Hamilton Depression Rating Scale (HAM-D-28), an appetite questionnaire, and regular weighing. In Study 1, response rates were 50% for both groups. Remission rates favored CHO (50% vs. 38%), as did the decrease in the HAM-D-17 score, but differences were nonsignificant. In Study 2, response rates were 71% for CHO and 76% for PRO, and remission rates were 71% for each group. Both treatment groups experienced significant improvement in HAM-D-17 scores within 1 week of treatment, which continued through the entire study period. Weight change did not differ significantly between treatment groups in either study. The drink mix was well tolerated and treatment adherence was high. Both the active and placebo intervention were effective in alleviating symptoms of SAD. Replication studies in larger samples appear warranted.

RCT Entities:   Population Interventions Outcomes