Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04123483
Status:
WITHDRAWN
Last Update Posted:
2020-01-02
First Post:
2019-10-09
Brief Title:
EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
EnBrace HR for Premenstrual Syndrome PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders MRMD
Status:
WITHDRAWN
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cancellation of funding contract
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 assess a novel nutritional supplement developed for prenatal health and mood benefits and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders MRMD including PMS with Prominent Mood Symptoms and PMDD
Detailed Description:
The luteal phase of the menstrual cycle also referred to as the premenstrual phase is a time of vulnerability for women during which many suffer from a number of physical and psychiatric symptoms Premenstrual mood symptoms affect a great proportion of women and can affect general wellbeing self-esteem occupational and social functioning and relationships A spectrum of severity exists around the manifestation of these symptoms and a range of terms can be used to refer to women with substantial psychiatric morbidity around the luteal phase of the menstrual cycle
Premenstrual Dysphoric Disorder PMDD has been formalized as a psychiatric diagnosis and added to the DSM-5 For a diagnosis of PMDD the diagnostic criteria include the following and must be met for most menstrual cycles in the preceding year A In the majority of cycles at least five symptoms must be present in the final week before the onset of menses and start to improve within a few days of its onset B One or more of the following must be present 1 affective lability 2 irritabilityanger or increased interpersonal conflicts 3 depressed mood hopelessness or self-deprecating thoughts 4 anxiety or tension Also one or more of the following must be present 1 decreased interest in usual activities 2 difficulty concentrating 3 low energy or fatigue 4 change in appetite or cravings 5 increased or decreased sleep 6 feeling overwhelmed or out of control 7 physical symptoms ie breast tenderness bloating weight gain
Several overlapping definitions and terms capture psychiatric distress related to the luteal phase of the menstrual cycle Many women suffer substantially during the premenstrual phase but do not have symptoms that fully meet criteria for PMDD The term menstrual related mood disorder MRMD has been used to describe conditions that include Premenstrual Dysphoric Disorder PMDD and also mood dysregulation related to the menstrual cycle that is clinically substantial but where the threshold for a PMDD formal diagnosis is not met Premenstrual Syndrome PMS refers to recurrent premenstrual symptoms that may include mood symptoms but mood symptoms may not be present in all women with PMSTherefore a subset of women with PMS with prominent or marked mood symptoms would be included under the category of MRMD Therefore in addition to those who meet full criteria for PMDD many women suffer from premenstrual syndrome PMS with prominent mood symptoms The term menstrual related mood disorder MRMD applies to women who may or may not meet the threshold for the formal PMDD diagnoses and represents a great number of women of reproductive age who suffer on a regular basis from luteal phase mood symptoms that compromise quality of life
Previous pre-clinical or clinical studies leading up to and supporting the research The prevalence of PMDD is between 3-8 of menstruating women in addition another 10-11 experience PMS with Prominent Mood Symptoms1 Based on these estimates 13-19 of menstruating women experience MRMD including those with both PMDD and PMS with prominent mood symptoms on a consistent basis
Menstrual related mood disorders MRMDs are characterized by prominent symptoms during the luteal phase of the cycle with relief starting with the onset of menses or soon after menses start The follicular phase is generally asymptomatic and the difference in symptom expression between worsening during the luteal phase and improvement during the follicular phase is its hallmark While many women recognize these patterns of cyclic mood worsening and the impact upon quality of life many women do not seek treatment For women who do seek treatment from health care providers the first line pharmacologic treatments are serotonergic antidepressants and oral contraceptive pills For women who prefer other options such as complementary and alternative medicine treatments or nutritional approaches few treatments have received rigorous study There is some promising but limited research with integrative treatments such as light therapy supplements and herbal treatments
Objective To evaluate the efficacy of EnBrace HR when used to treat premenstrual syndromes PMS with predominant mood symptoms also referred to as MRMD
Specific Aim 1 To evaluate the effect of treatment with EnBrace HR in women with prominent mood symptoms in the premenstrual phase of the menstrual cycle EnBrace will be administered in a continuous daily regimen and the outcome will be the effect on the mean DRSP during the luteal phase from baseline to the treatment cycle 1 and 2 assessments
Exploratory Aims To evaluate the effect of EnBrace HR with respect to
1 Mean change from baseline to endpoint in CGI-S scores
2 Tolerability and safety
3 To assess whether biomarkers can be identified that appear to be associated with treatment response to EnBrace HR
The current study will provide evidence regarding the efficacy tolerability feasibility and acceptability of a selected non-psychotropic treatment alternative to serotonergic antidepressants and oral contraceptive pills We hypothesize that the prevalence of PMDD MRMD and PMS in menstruating women may be attenuated if there are other effective treatments available to women
Premenstrual Dysphoric Disorder PMDD has been formalized as a psychiatric diagnosis and added to the DSM-5 For a diagnosis of PMDD the diagnostic criteria include the following and must be met for most menstrual cycles in the preceding year A In the majority of cycles at least five symptoms must be present in the final week before the onset of menses and start to improve within a few days of its onset B One or more of the following must be present 1 affective lability 2 irritabilityanger or increased interpersonal conflicts 3 depressed mood hopelessness or self-deprecating thoughts 4 anxiety or tension Also one or more of the following must be present 1 decreased interest in usual activities 2 difficulty concentrating 3 low energy or fatigue 4 change in appetite or cravings 5 increased or decreased sleep 6 feeling overwhelmed or out of control 7 physical symptoms ie breast tenderness bloating weight gain
Several overlapping definitions and terms capture psychiatric distress related to the luteal phase of the menstrual cycle Many women suffer substantially during the premenstrual phase but do not have symptoms that fully meet criteria for PMDD The term menstrual related mood disorder MRMD has been used to describe conditions that include Premenstrual Dysphoric Disorder PMDD and also mood dysregulation related to the menstrual cycle that is clinically substantial but where the threshold for a PMDD formal diagnosis is not met Premenstrual Syndrome PMS refers to recurrent premenstrual symptoms that may include mood symptoms but mood symptoms may not be present in all women with PMSTherefore a subset of women with PMS with prominent or marked mood symptoms would be included under the category of MRMD Therefore in addition to those who meet full criteria for PMDD many women suffer from premenstrual syndrome PMS with prominent mood symptoms The term menstrual related mood disorder MRMD applies to women who may or may not meet the threshold for the formal PMDD diagnoses and represents a great number of women of reproductive age who suffer on a regular basis from luteal phase mood symptoms that compromise quality of life
Previous pre-clinical or clinical studies leading up to and supporting the research The prevalence of PMDD is between 3-8 of menstruating women in addition another 10-11 experience PMS with Prominent Mood Symptoms1 Based on these estimates 13-19 of menstruating women experience MRMD including those with both PMDD and PMS with prominent mood symptoms on a consistent basis
Menstrual related mood disorders MRMDs are characterized by prominent symptoms during the luteal phase of the cycle with relief starting with the onset of menses or soon after menses start The follicular phase is generally asymptomatic and the difference in symptom expression between worsening during the luteal phase and improvement during the follicular phase is its hallmark While many women recognize these patterns of cyclic mood worsening and the impact upon quality of life many women do not seek treatment For women who do seek treatment from health care providers the first line pharmacologic treatments are serotonergic antidepressants and oral contraceptive pills For women who prefer other options such as complementary and alternative medicine treatments or nutritional approaches few treatments have received rigorous study There is some promising but limited research with integrative treatments such as light therapy supplements and herbal treatments
Objective To evaluate the efficacy of EnBrace HR when used to treat premenstrual syndromes PMS with predominant mood symptoms also referred to as MRMD
Specific Aim 1 To evaluate the effect of treatment with EnBrace HR in women with prominent mood symptoms in the premenstrual phase of the menstrual cycle EnBrace will be administered in a continuous daily regimen and the outcome will be the effect on the mean DRSP during the luteal phase from baseline to the treatment cycle 1 and 2 assessments
Exploratory Aims To evaluate the effect of EnBrace HR with respect to
1 Mean change from baseline to endpoint in CGI-S scores
2 Tolerability and safety
3 To assess whether biomarkers can be identified that appear to be associated with treatment response to EnBrace HR
The current study will provide evidence regarding the efficacy tolerability feasibility and acceptability of a selected non-psychotropic treatment alternative to serotonergic antidepressants and oral contraceptive pills We hypothesize that the prevalence of PMDD MRMD and PMS in menstruating women may be attenuated if there are other effective treatments available to women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None