Examination of a Soy-Based Supplement for Major Depression
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out if the soy-based dietary supplement Novasoy
(Registered Trademark) is effective for the short-term treatment of clinical depression. This
study will also evaluate whether Novasoy (Registered Trademark) is effective in treating the
anxiety that often accompanies depression and will assess the best dose level.
Novasoy (Registered Trademark) is a marketed botanical dietary supplement containing soy
isoflavones. The active form of the soy isoflavone genistin may be a novel treatment for
neuropsychiatric illnesses. The soy isoflavone's specific hormonal properties may also have
beneficial effects on brain function in depressed patients.
This study will be conducted in two phases. During Phase I, participants will stop all
medications for at least 1 week. A psychiatric and medical examination will be conducted.
During Phase II, participants will be randomly assigned to receive either Novasoy (Registered
Trademark) or a placebo (an inactive pill) for 8 weeks. Participants who do not respond to
treatment after 5 weeks will be given a higher dose of their assigned medication. After the
8-week period, participants will be monitored for up to 3 months before being referred back
to their clinician for further treatment.