Examination of a Soy-Based Supplement for Major Depression
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:||A Phase 2A Study of Soy Isoflavones in the Treatment of Major Depression|
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||April 2005|
Recurrent mood disorders can have devastating long-term effects, and the cost of these illnesses in terms of human suffering, productivity and health care is enormous. It is now recognized that, for many patients, the long-term outcome is often much less favorable than previously thought, with incomplete inter-episode recovery, and a progressive decline in overall functioning observed. Indeed, according to the Global Burden of Disease Study, mood disorders are among the leading causes of disability worldwide, and are likely to represent an increasingly greater health, societal, and economic problem in the coming years. Dietary and nutritionally derived botanical compounds offer promise both for experimental therapeutics of complex diseases and for chemoprevention of illnesses such as depression.
Genistein is a polyphenolic molecule and the active form of the soy isoflavone, genistin. It has both phytoestrogen and protein tyrosine kinase inhibiting properties. Since tyrosine phosphorylation is involved in central nervous system regulation of neurotransmission inhibition by genistein may be a novel strategy to directly modulate synaptic activity and treat neuropsychiatric illnesses. Genistein's specific hormonal properties may also have salutary effects on brain function in depressed patients. Genistein increases dopamine and other monoamine activity, affects neurotrophic factor transcription, and has neuroprotective properties.
This is an 8-week double blind parallel study that will examine the efficacy and safety of Novasoy® (Registered Trademark) (CAS 446-72-0), a marketed botanical dietary supplement, in acutely depressed male and female patients (n&eq;60 in each group). The study has two Periods. Study Period I is a washout phase (1 week) and evaluation period. Study Period II is a monotherapy 8-week parallel, placebo controlled, acute treatment phase in which the efficacy and tolerability of isoflavones is compared to baseline. After completing the 8-week study period, subjects will be followed at the mood disorders clinic at NIMH for any necessary treatment adjustment and referred back to their clinician for further treatment.
Patients, ages 18 and over, with a diagnosis of major depression (without psychotic features), will be titrated onto an isoflavone mixture, Novasoy® (Registered Trademark), to a specific target dose (genistin &eq; 270mg/day in divided doses). At the end of week 5 nonresponders (less or equal to 50% improvement) will have one further titration to a higher dose (genistin&eq;360 mg/day in divided doses). Primary efficacy will be determined by demonstrating a greater response rate using a well-validated rating scale. Subjects will be randomized 1:1 with stratification for sex. Improvement in depressive symptoms is hypothesized to be significantly greater in the active soy isoflavone group.
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|