Premenstrual SyndromePhase 4NCT04123483
EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders
A Phase 4 study testing EnBrace HR Softgel in people with Premenstrual Syndrome and Premenstrual Dysphoric Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Premenstrual Tension
- What is being tested?
- EnBrace HR Softgel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regular menstrual cycles, 23-35 days in length.
- MRMD diagnosis based on the DRSP items, with: at least 1 or more core symptoms occurring during the luteal phase of the menstrual cycle for at least the past three months by patient history, including: 1) low mood, 2) hopelessness, 3) feeling worthless or guilty, 4) feeling anxious or "keyed up" or "on edge," 5) mood swings, 6) more sensitive to rejection or to hurt feelings, 7) feeling angry/irritable, or 8) having interpersonal conflicts.
- Patients must also have at least 1 associated symptom on the DRSP that is not considered a core symptom that occurs during the luteal/premenstrual phase of the menstrual cycle.
- Currently experiencing clinically significant MRMD symptoms, defined as ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
- Negative serum Human Chorionic Gonadotropin (HCG) at baseline, and negative urine HCG at visits 3 and 5.
- Willingness to use adequate contraceptive methods during the study, if sexually active. Hormonal contraceptives are allowed if the premenstrual symptoms still meet study criteria despite use and patient has been on a stable regimen for >3 months.
- Good general health.
Who cannot join
- Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 2 months.
- Pregnant and lactating women.
- Women taking a prenatal vitamin, methotrexate, fluorouracil, colchicine, bromocriptine, Gonadotropin-Releasing Hormone (GnRH) agonists, vitamin B6 (>100 mg), calcium supplements (>1500 mg per day), or para-aminosalicylic acid.
- Significant risk for self-harm or harm to others.
- Meet criteria for a primary diagnosis of schizophrenia, bipolar disorder, an active eating disorder of anorexia or bulimia, dementia, delirium, or other cognitive disorder.
- Current major depressive episode or anxiety disorder that is a primary focus of current treatment. Patients may be on an antidepressant used for maintenance treatment if the dose is not changed intermittently to address premenstrual symptoms; dose must be stable for at least 8 weeks prior to study entry.
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- Presence of an active substance and/or alcohol abuse disorder within six months prior to screening.
- Known low B12 levels, pPernicious anemia or history of gastric bypass surgery or bariatric surgery.
- Seizure disorder or current use of an anticonvulsant medication
- Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)
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.
Read the 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) irritability/anger 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 (i.e., 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 PMS.Therefore, 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 Symptoms.1 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:
- Mean change from baseline to endpoint in CGI-S scores
- Tolerability and safety
- 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.
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Premenstrual Tension, Menstrual Related Mood Disorder
- Being tested
- EnBrace HR Softgel
- Keywords
- PMS, Folate, Omega-3 Fatty Acids, Vitamins, Women's Health, Dietary Supplements, PMDD, MRMD, Menstrual Related Mood Disorder, Premenstrual Tension
- Medical subject headings
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnBrace HR SoftgelDrug
Also called EnBrace HR
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study
| Study group | Role | What they receive |
|---|---|---|
| EnBrace HR for Acute Treatment of PMS and MRMD | Experimental | Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 weeks. Participants are currently experiencing clinically significant MRMD symptoms, defined as a ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding). Receives: Drug: EnBrace HR Softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment Response to EnBrace Therapy Measured Using The Daily Record of Severity of Problems (DRSP)
Experience a response (50% improvement in MRMD symptoms) to EnBrace therapy, as assessed by the DRSP (≥ 50% decrease in DRSP score during the luteal phase). The DSRP involves daily rating of scale items and ranking based on severity for each day of the menstrual cycle. The DRSP includes 21 symptom items grouped within 11 domains. An individual records the score for each item on each day using the following scale of 1 to 6: 1=not at all, 2=minimal, 3=mild, 4=moderate, 5=severe, 6=extreme. Clinically significant MRMD symptoms are defined as a ≥ 30% increase in the total DRSP score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
Measured: Assessed daily for 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Cancellation of funding contract
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot study of EnBrace HR in a single group of women who experience PMS with prominent mood symptoms or a menstrual related mood disorder (MRMD). All women will be experiencing clinically significant menstrual related mood symptoms at the time of enrollment. In this study, EnBrace HR is studied for acute treatment PMS with prominent mood symptoms and MRMD.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene P. Freeman, Massachusetts General Hospital
- Investigators
- Marlene P Freeman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123483
- Sponsor's protocol ID
- 2019P002454
- Status last verified
- Dec 2019
- First submitted
- 9 Oct 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)
- ClinicalTrials.gov ID
- NCT04123483
- Acronym / sponsor ID
- 2019P002454
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Premenstrual Tension, Menstrual Related Mood Disorder
- Keywords
- PMS, Folate, Omega-3 Fatty Acids, Vitamins, Women's Health, Dietary Supplements, PMDD, MRMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancellation of funding contract
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) irritability/anger 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 (i.e., 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 PMS.Therefore, 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 Symptoms.1 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:
- Mean change from baseline to endpoint in CGI-S scores
- Tolerability and safety
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot study of EnBrace HR in a single group of women who experience PMS with prominent mood symptoms or a menstrual related mood disorder (MRMD). All women will be experiencing clinically significant menstrual related mood symptoms at the time of enrollment. In this study, EnBrace HR is studied for acute treatment PMS with prominent mood symptoms and MRMD.
| Arm | Type | Receives |
|---|---|---|
| EnBrace HR for Acute Treatment of PMS and MRMD | Experimental | Drug: EnBrace HR SoftgelPrescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 weeks. Participants are currently experiencing clinically significant MRMD symptoms, defined as a ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding). |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Regular menstrual cycles, 23-35 days in length.
- MRMD diagnosis based on the DRSP items, with: at least 1 or more core symptoms occurring during the luteal phase of the menstrual cycle for at least the past three months by patient history, including: 1) low mood, 2) hopelessness, 3) feeling worthless or guilty, 4) feeling anxious or "keyed up" or "on edge," 5) mood swings, 6) more sensitive to rejection or to hurt feelings, 7) feeling angry/irritable, or 8) having interpersonal conflicts.
- Patients must also have at least 1 associated symptom on the DRSP that is not considered a core symptom that occurs during the luteal/premenstrual phase of the menstrual cycle.
- Currently experiencing clinically significant MRMD symptoms, defined as ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
- Negative serum Human Chorionic Gonadotropin (HCG) at baseline, and negative urine HCG at visits 3 and 5.
Key exclusion criteria (11 listed)
- Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 2 months.
- Pregnant and lactating women.
- Women taking a prenatal vitamin, methotrexate, fluorouracil, colchicine, bromocriptine, Gonadotropin-Releasing Hormone (GnRH) agonists, vitamin B6 (>100 mg), calcium supplements (>1500 mg per day), or para-aminosalicylic acid.
- Significant risk for self-harm or harm to others.
- Meet criteria for a primary diagnosis of schizophrenia, bipolar disorder, an active eating disorder of anorexia or bulimia, dementia, delirium, or other cognitive disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnBrace HR SoftgelAlso: EnBrace HRPrescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study | Drug | EnBrace HR for Acute Treatment of PMS and MRMD |
Primary outcome
Rate of Treatment Response to EnBrace Therapy Measured Using The Daily Record of Severity of Problems (DRSP)
Time frame: Assessed daily for 8 weeks of treatment
Experience a response (50% improvement in MRMD symptoms) to EnBrace therapy, as assessed by the DRSP (≥ 50% decrease in DRSP score during the luteal phase). The DSRP involves daily rating of scale items and ranking based on severity for each day of the menstrual cycle. The DRSP includes 21 symptom items grouped within 11 domains. An individual records the score for each item on each day using the following scale of 1 to 6: 1=not at all, 2=minimal, 3=mild, 4=moderate, 5=severe, 6=extreme. Clinically significant MRMD symptoms are defined as a ≥ 30% increase in the total DRSP score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene P Freeman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EnBrace HR Softgel in people with Premenstrual Syndrome and Premenstrual Dysphoric Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Treatment Response to EnBrace Therapy Measured Using The Daily Record of Severity of Problems (DRSP) (time frame: Assessed daily for 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.