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NCT00042380 · ClinicalTrials.gov registry record · Phase 2
Examination of a Soy-Based Supplement for Major Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00042380 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 120 participants.
The verdict
NCT00042380, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
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.
Interventions
- DRUG Novasoy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2002-07 |
| Est. Completion | 2005-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00042380
The ClinicalTrials.gov registry entry for NCT00042380 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Novasoy is the first listed.
NCT00042380 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00042380 about?
NCT00042380 is a clinical study titled "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 accompani...
What is the current status of trial NCT00042380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2002-07. Estimated completion is 2005-04.
What interventions are being tested in trial NCT00042380?
The interventions under investigation include: Novasoy (DRUG).
Who is sponsoring clinical trial NCT00042380?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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