Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042380
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-07-26
Brief Title:
Examination of a Soy-Based Supplement for Major Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase 2A Study of Soy Isoflavones in the Treatment of Major Depression
Status:
COMPLETED
Status Verified Date:
2005-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 isoflavones 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
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 isoflavones 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
Detailed Description:
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 Genisteins 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 neq60 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 270mgday 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 genistineq360 mgday in divided doses Primary efficacy will be determined by demonstrating a greater response rate using a well-validated rating scale Subjects will be randomized 11 with stratification for sex Improvement in depressive symptoms is hypothesized to be significantly greater in the active soy isoflavone group
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 Genisteins 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 neq60 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 270mgday 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 genistineq360 mgday in divided doses Primary efficacy will be determined by demonstrating a greater response rate using a well-validated rating scale Subjects will be randomized 11 with stratification for sex Improvement in depressive symptoms is hypothesized to be significantly greater in the active soy isoflavone group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0254 | None | None | None |