Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517985
Status:
COMPLETED
Last Update Posted:
2012-07-09
First Post:
2007-03-09
Brief Title:
Duloxetine for Perimenopausal Depression
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Duloxetine for Perimenopausal Depression
Status:
COMPLETED
Status Verified Date:
2012-07
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 have been explored as a class of medications to treat major depression in the context of perimenopause as well as the somatic symptoms of perimenopause such as hot flashes Duloxetine Cymbalta is one of the newer antidepressants approved for the treatment of Major Depressive Disorder MDD Therefore the current study is designed to assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet criteria for MDD We will assess impact on MDD and perimenopausal symptoms
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 Perimenopausal depression postpartum depression and unpleasant disturbing emotional and physical symptoms that occur just before monthly menstrual periods have been shown to occur during times of fluctuating levels of estrogen and other gonadal hormones
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 particularly high risk for depressive symptoms during perimenopause due to declining levels of estrogen In a previous study women at risk for postpartum depression were found to benefit from estrogen replacement therapy However hormone replacement therapy HRT has become increasingly controversial in light of the findings of the Womens Health Initiative study that determined that women who received estrogen plus progestin were slightly more likely to suffer from coronary heart disease strokes blood clots in the lungs and invasive breast cancer Since the report of these results HRT use has declined and as an alternative treatment for depression antidepressants have been increasingly utilized for perimenopausal women Fluoxetine paroxetine and venlafaxine are members of a new class of drugs called selective serotonin reuptake inhibitors SSRIs and which have all been demonstrated to be beneficial in the treatment of hot flashes Recently a new second-generation drug Duloxetine Cymbalta has also been approved for the treatment of major depression This drug is a member of a class of compounds that are referred to as serotonin-norepinephrine reuptake inhibitors SNRIs The method by which Duloxetine and members of this group achieve their effect is similar to that of the other antidepressant agents that have been used Recent studies have indicated that Duloxetine appears to provide relief for both the mood and physical components of perimenopause
In order to continue studying the benefits of Duloxetine in subjects with perimenopause this study is designed to enroll 20 perimenopausal women with depression in a 9-week trial Subjects cannot be enrolled in the study if they are currently using hormone replacement therapy and all patients must meet the criteria for a major depressive episode which will be verified by the standardized protocol for establishing depression the Structured Clinical Interview for DSM-IV SCID
Subjects enrolled in the study will undergo 7 total clinic visits during a 9-week study period The first visit will last approximately 3 hours with all other visits taking approximately 45 minutes During the 1st visit medical and psychiatric history will be reviewed and blood will be drawn approximately 3 teaspoons Blood will be used for routine laboratory testing Urine will also be collected for a pregnancy test
For Major Depressive Disorder the FDA has recommended that a total dose of 40 mgday 20 mg taken twice a day to 60 mgday given either once a day or as 30 mg twice a day be administered without regard to meals While a 120 mgday dose has been shown to be safe and effective there is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated During the current study for a short period of time participants will receive a placebo a pill that looks like the study drug but which does not contain any medication although during the majority of the study participants will be receiving the actual study medication Duloxetine The initial dose of Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per day This study will be blinded meaning that participants will not know whether they are taking placebo or the study drug However all subjects will receive duloxetine for the majority of the time they are enrolled in the trial Investigators will know when subjects are receiving the placebo but in order to maintain the blinding of this study the study staff will not be able to tell participants when they are taking placebo and when they are taking Duloxetine
After the consent forms are read and signed participants will undergo a Structured Clinical Interview for DSM-IV SCID interview In addition symptoms will also be rated by rating scales that include the Clinical Global Impression CGI the Greene Climacteric Scale GCS and the Hamilton Depression Rating Scale HAM-D 17-item To determine functional assessment in all participants the Global Assessment Scale GAF will be used All participants will also undergo an interview that will include a psychiatric and substance use history including collection of data regarding the use of alcohol tobacco and illicit substances
Medical screening will occur in conjunction with the initial entry interview All patients must have had a gynecologic exam within the past year and if not study personnel will provide a referral for an exam The investigators will review the patients medical history Laboratory tests will include thyroid function tests TFTs liver function tests LFTs renal panel pregnancy tests and complete blood count CBC Subjects will also complete the Greene Climacteric Scale which is used to quantify the severity of perimenopausal symptoms
At each of the visits all participants will be administered the CGI HAM-D and GCS questionnairessurveys in addition to The Greene Climacteric Scale which will be used to quantify symptoms of perimenopause Also participants will be asked at each visit if they have missed any doses during that particular week Each of the office visits will last approximately 45 minutes If necessary telephone contact with investigators is permissible and will be available 24 hoursday for emergencies
Safety and tolerability will be assessed throughout the study At each study visit information on any side effects that may have occurred will be collected In the rare event that a side effect or adverse event does occurs participants will be able to contact any of the studys research clinicians Emergency contact personnel will be on-call 24 hours per day seven days per week
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 particularly high risk for depressive symptoms during perimenopause due to declining levels of estrogen In a previous study women at risk for postpartum depression were found to benefit from estrogen replacement therapy However hormone replacement therapy HRT has become increasingly controversial in light of the findings of the Womens Health Initiative study that determined that women who received estrogen plus progestin were slightly more likely to suffer from coronary heart disease strokes blood clots in the lungs and invasive breast cancer Since the report of these results HRT use has declined and as an alternative treatment for depression antidepressants have been increasingly utilized for perimenopausal women Fluoxetine paroxetine and venlafaxine are members of a new class of drugs called selective serotonin reuptake inhibitors SSRIs and which have all been demonstrated to be beneficial in the treatment of hot flashes Recently a new second-generation drug Duloxetine Cymbalta has also been approved for the treatment of major depression This drug is a member of a class of compounds that are referred to as serotonin-norepinephrine reuptake inhibitors SNRIs The method by which Duloxetine and members of this group achieve their effect is similar to that of the other antidepressant agents that have been used Recent studies have indicated that Duloxetine appears to provide relief for both the mood and physical components of perimenopause
In order to continue studying the benefits of Duloxetine in subjects with perimenopause this study is designed to enroll 20 perimenopausal women with depression in a 9-week trial Subjects cannot be enrolled in the study if they are currently using hormone replacement therapy and all patients must meet the criteria for a major depressive episode which will be verified by the standardized protocol for establishing depression the Structured Clinical Interview for DSM-IV SCID
Subjects enrolled in the study will undergo 7 total clinic visits during a 9-week study period The first visit will last approximately 3 hours with all other visits taking approximately 45 minutes During the 1st visit medical and psychiatric history will be reviewed and blood will be drawn approximately 3 teaspoons Blood will be used for routine laboratory testing Urine will also be collected for a pregnancy test
For Major Depressive Disorder the FDA has recommended that a total dose of 40 mgday 20 mg taken twice a day to 60 mgday given either once a day or as 30 mg twice a day be administered without regard to meals While a 120 mgday dose has been shown to be safe and effective there is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated During the current study for a short period of time participants will receive a placebo a pill that looks like the study drug but which does not contain any medication although during the majority of the study participants will be receiving the actual study medication Duloxetine The initial dose of Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per day This study will be blinded meaning that participants will not know whether they are taking placebo or the study drug However all subjects will receive duloxetine for the majority of the time they are enrolled in the trial Investigators will know when subjects are receiving the placebo but in order to maintain the blinding of this study the study staff will not be able to tell participants when they are taking placebo and when they are taking Duloxetine
After the consent forms are read and signed participants will undergo a Structured Clinical Interview for DSM-IV SCID interview In addition symptoms will also be rated by rating scales that include the Clinical Global Impression CGI the Greene Climacteric Scale GCS and the Hamilton Depression Rating Scale HAM-D 17-item To determine functional assessment in all participants the Global Assessment Scale GAF will be used All participants will also undergo an interview that will include a psychiatric and substance use history including collection of data regarding the use of alcohol tobacco and illicit substances
Medical screening will occur in conjunction with the initial entry interview All patients must have had a gynecologic exam within the past year and if not study personnel will provide a referral for an exam The investigators will review the patients medical history Laboratory tests will include thyroid function tests TFTs liver function tests LFTs renal panel pregnancy tests and complete blood count CBC Subjects will also complete the Greene Climacteric Scale which is used to quantify the severity of perimenopausal symptoms
At each of the visits all participants will be administered the CGI HAM-D and GCS questionnairessurveys in addition to The Greene Climacteric Scale which will be used to quantify symptoms of perimenopause Also participants will be asked at each visit if they have missed any doses during that particular week Each of the office visits will last approximately 45 minutes If necessary telephone contact with investigators is permissible and will be available 24 hoursday for emergencies
Safety and tolerability will be assessed throughout the study At each study visit information on any side effects that may have occurred will be collected In the rare event that a side effect or adverse event does occurs participants will be able to contact any of the studys research clinicians Emergency contact personnel will be on-call 24 hours per day seven days per week
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