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Examination of a Soy-Based Supplement for Major Depression

NCT00042380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-03-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Novasoy

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2005-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00042380 on ClinicalTrials.gov