Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517972
Status:
WITHDRAWN
Last Update Posted:
2012-03-29
First Post:
2007-08-15
Brief Title:
Omacor for Perimenopausal Depression
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Omacor for Perimenopausal Depression
Status:
WITHDRAWN
Status Verified Date:
2012-03
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:
Recently antidepressants and other similar acting agents have been explored as a class of medications to treat major depressive disorder MDD in the context of perimenopause as well as the somatic symptoms of perimenopause such as hot flashes Omega-3 fatty acids which include eicosapentaenoic acid EPA and docosahexaenoic acid DHA are nutritional compounds with widely established health benefits and which occur naturally in fish and marine sources Results of previous mood disorder studies have indicated that omega-3 fatty acids may be of help in the treatment of depression Therefore the current study is designed to examine the effectiveness and tolerability of the study drug Omacor omega-3 fatty acid ethyl esters in the treatment of major depressive disorder in perimenopausal women
Detailed Description:
Over twenty percent of women will experience a major depressive episode in their lifetimes a prevalence that reflects a greater risk than is found among men Perimenopause is commonly defined as a time of hormonal fluctuation that typically occurs in women 40-55 years of age with changes in menstrual patterns It has been demonstrated that women may be at a particularly high risk for depressive symptoms during perimenopause Hormone replacement therapy particularly estrogen may help with mood symptoms in the perimenopause However hormone replacement therapy HRT has become increasingly controversial in light of the findings of the Womens Health Initiative study In that study HRT was associated with an increased risk of some serious health problems without many of the benefits which had been previously attributed to HRT Since the report of these results HRT use has declined and other agents such as antidepressants have been used as an alternative treatment for depression in perimenopausal women
Optimal treatments for depression must be safe and effective with ideal treatments also providing other health benefits as well Omega-3 fatty acids are nutritional compounds with widely established health benefits Eicosapentaenoic acid EPA and docosahexaenoic acid DHA are omega-3 fatty acids found in fish and marine sources Mood disorder studies have supported a role for omega-3 fatty acids in the treatment of depression In a study from 1998 it was demonstrated in a cross-national study that the risk of major depression is inversely associated with per capita fish consumption Several other studies have demonstrated that in depressed subjects there is a lower total omega-3 fatty acid content in the membranes of red blood cells and plasma liquid part of the blood when compared to control subjects Treatment data from studies of major depressive disorder also support a role for omega-3 fatty acids especially when omega-3 fatty acids are used as an adjunctive treatment ie fatty acids are administered along with another therapeutic compound during treatment of major depressive disorder
It has also been demonstrated that the use of antidepressants such as fluoxetine paroxetine and venlafaxine for treatment of hot flashes and citalopram for the treatment of hot flashes and mood in perimenopausal women are more effective than placebo However antidepressant medications are associated with significant side effects and as of late have come under increased scrutiny by the US FDA the psychiatric and general medical community due to the ongoing controversy regarding a possible increased risk of suicidality after the initiation of antidepressant treatment While there is not complete agreement on the mechanism of action for omega-3 fatty acids like antidepressants overall data suggests that omega-3 fatty acids may be beneficial for treatment of perimenopausal depression However unlike antidepressants omega-3 fatty acids are naturally occurring substances which may appeal to many individuals suffering from perimenopausal depression Omega-3 fatty acids have known benefits for cardiovascular health Therefore the current study is designed to examine the effectiveness and tolerability of the study drug Omacor omega-3 fatty acid ethyl esters in the treatment of major depression in perimenopausal women
Subjects that take part in this voluntary study will undergo 6 clinic visits during the 8-week study period The first visit may last up to 3 hours with all other clinic visits lasting approximately 45 minutes Once the consent form has been read and signed subjects will be enrolled in the study At the first visit medical and psychiatric histories will be reviewed All participants will undergo the standardized protocol for establishing depression the Structured Clinical Interview for DSM-IV SCID in addition to being rated by symptom rating scales that include the Clinical Global Impression CGI and the Hamilton Depression Rating Scale HAM-D 17-item All participants will also undergo an entry interview that will include a psychiatric and substance use history including data regarding use of alcohol tobacco and illicit substances During the initial exam vital signs height weight and blood pressure will also be recorded for all participants In addition all subjects that are enrolled must have had a gynecologic exam within the past year or if not will be given a referral for such an exam Blood approximately 3 teaspoons will be drawn for routine laboratory testing thyroid function tests TFTs and complete blood count CBC and a lipid profile Blood will also be drawn approximately 3 teaspoons at the last visit for the purpose of repeating the lipid profile Subjects will also complete the Greene Climacteric Scale GCS which is used to quantify the severity of perimenopausal somatic symptoms including hot flashes
As this study will be examining omega-3 fatty acids subjects will not be eligible to participate in the study if they are taking omega-3 fatty acid supplements In addition once enrolled in the study all participants will be asked to avoid taking additional omega-3 fatty acids or enhanced food products and will need to avoid increasing or decreasing the amount of fish that they normally eat during the entire time of the study
Once all interviews and medical screens are finished all participants will receive the study medication Omacor The study drug will be supplied in 1 gram capsules and participants will need to take two capsules at the same time every day Thus all subjects will be taking a total of 2 grams of Omacor per day
Questions about mood and perimenopausal symptoms will be asked at each visit At each of these visits the primary efficacy measures CGI HAM-D and GCS will be administered The GCS will be completed at each visit to quantify the somatic symptoms of perimenopause Subjects will also be asked the about number of missed doses each week
Telephone contact with investigators is permissible and will be available 24 hoursday for emergencies All contacts will be documented in the participants records
Optimal treatments for depression must be safe and effective with ideal treatments also providing other health benefits as well Omega-3 fatty acids are nutritional compounds with widely established health benefits Eicosapentaenoic acid EPA and docosahexaenoic acid DHA are omega-3 fatty acids found in fish and marine sources Mood disorder studies have supported a role for omega-3 fatty acids in the treatment of depression In a study from 1998 it was demonstrated in a cross-national study that the risk of major depression is inversely associated with per capita fish consumption Several other studies have demonstrated that in depressed subjects there is a lower total omega-3 fatty acid content in the membranes of red blood cells and plasma liquid part of the blood when compared to control subjects Treatment data from studies of major depressive disorder also support a role for omega-3 fatty acids especially when omega-3 fatty acids are used as an adjunctive treatment ie fatty acids are administered along with another therapeutic compound during treatment of major depressive disorder
It has also been demonstrated that the use of antidepressants such as fluoxetine paroxetine and venlafaxine for treatment of hot flashes and citalopram for the treatment of hot flashes and mood in perimenopausal women are more effective than placebo However antidepressant medications are associated with significant side effects and as of late have come under increased scrutiny by the US FDA the psychiatric and general medical community due to the ongoing controversy regarding a possible increased risk of suicidality after the initiation of antidepressant treatment While there is not complete agreement on the mechanism of action for omega-3 fatty acids like antidepressants overall data suggests that omega-3 fatty acids may be beneficial for treatment of perimenopausal depression However unlike antidepressants omega-3 fatty acids are naturally occurring substances which may appeal to many individuals suffering from perimenopausal depression Omega-3 fatty acids have known benefits for cardiovascular health Therefore the current study is designed to examine the effectiveness and tolerability of the study drug Omacor omega-3 fatty acid ethyl esters in the treatment of major depression in perimenopausal women
Subjects that take part in this voluntary study will undergo 6 clinic visits during the 8-week study period The first visit may last up to 3 hours with all other clinic visits lasting approximately 45 minutes Once the consent form has been read and signed subjects will be enrolled in the study At the first visit medical and psychiatric histories will be reviewed All participants will undergo the standardized protocol for establishing depression the Structured Clinical Interview for DSM-IV SCID in addition to being rated by symptom rating scales that include the Clinical Global Impression CGI and the Hamilton Depression Rating Scale HAM-D 17-item All participants will also undergo an entry interview that will include a psychiatric and substance use history including data regarding use of alcohol tobacco and illicit substances During the initial exam vital signs height weight and blood pressure will also be recorded for all participants In addition all subjects that are enrolled must have had a gynecologic exam within the past year or if not will be given a referral for such an exam Blood approximately 3 teaspoons will be drawn for routine laboratory testing thyroid function tests TFTs and complete blood count CBC and a lipid profile Blood will also be drawn approximately 3 teaspoons at the last visit for the purpose of repeating the lipid profile Subjects will also complete the Greene Climacteric Scale GCS which is used to quantify the severity of perimenopausal somatic symptoms including hot flashes
As this study will be examining omega-3 fatty acids subjects will not be eligible to participate in the study if they are taking omega-3 fatty acid supplements In addition once enrolled in the study all participants will be asked to avoid taking additional omega-3 fatty acids or enhanced food products and will need to avoid increasing or decreasing the amount of fish that they normally eat during the entire time of the study
Once all interviews and medical screens are finished all participants will receive the study medication Omacor The study drug will be supplied in 1 gram capsules and participants will need to take two capsules at the same time every day Thus all subjects will be taking a total of 2 grams of Omacor per day
Questions about mood and perimenopausal symptoms will be asked at each visit At each of these visits the primary efficacy measures CGI HAM-D and GCS will be administered The GCS will be completed at each visit to quantify the somatic symptoms of perimenopause Subjects will also be asked the about number of missed doses each week
Telephone contact with investigators is permissible and will be available 24 hoursday for emergencies All contacts will be documented in the participants records
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