Protocol Number: 02-M-0254

Title:

A Phase 2A Study of Soy Isoflavones in the Treatment of Major Depression

Number:

02-M-0254

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Antidepressant

Anxiety

Dopamine

Tyrosine Kinase Inhibitor

Affective Disorder

Phytoestrogen

Genistein

Major Depression

Recruitment Keywords:

Depression

Major Depression

Affective Disorder

Conditions:

Depression

Investigational Drug(s):

Novasoy

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Tohen M, Hennen J, Two-year syndromal and functional recovery in 219 cases of first-episode major affective disorder with psychotic features Am J Psychiatry 2000 Feb;157(2):220-8 PMID: 10671390

Murray CJ, Lopez AD Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease StudyLancet 1997 May 24;349(9064):1498-504 PMID: 9167458

Musselman DL, Evans DL, Nemeroff CB The relationship of depression to cardiovascular disease: epidemiology, biology, and treatment Arch Gen Psychiatry 1998 Jul;55(7):580-92 Review PMID: 9672048

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004