RAPID: Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01654796
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Yale University (Other), Icahn School of Medicine at Mount Sinai (Other), University of Texas Southwestern Medical Center (Other), University of Alabama at Birmingham (Other), Emory University (Other)
• Enrollment: 84
• Locations: 6
• Arms: 3
• Actual Duration (Months): 41
• Patients Per Site: 14
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression	Device: Low Field Magnetic Stimulation (LFMS); Device: Sham LFMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low Field Magnetic Stimulation Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.	Device: Low Field Magnetic Stimulation (LFMS); The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Placebo Comparator: Sham (LFMS) Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.	Device: Sham LFMS; Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
Other: Crossover Arm Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.	Device: Low Field Magnetic Stimulation (LFMS); The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.; Device: Sham LFMS; Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Outcome Measures

Primary Outcome Measures

1. Hamilton Rating Scale for Depression - 6 Items [Baseline and 48 hours after initiating treatment]

   The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, 18-65 years old

• Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks

• A participant has Treatment Resistant Depression (TRD) of the current MDE

• Good general health

• For female participants, status of non-childbearing potential or use of an acceptable form of birth control

• Body mass index between 18-40 kg/m2

• Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening and is expected to remain stable during participation in the study

• Concurrent hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable during the subject's participation in the study

• Participant must be able to lie flat for 20 minutes

Exclusion Criteria:

• A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study

• Pregnant or breastfeeding

• A woman with a positive pregnancy test at screening or baseline

• Participant has TRD of the current MDE with failure to achieve a satisfactory response, as perceived by the subject, to more than 3 treatment courses of a therapeutic dose of an antidepressant therapy of at least eight weeks duration

• Participant has a current diagnosis of a Substance Use Disorder with the exception of nicotine dependence, at screening or within six months prior to screening

• Current diagnosis of Axis I disorders other than Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Specific Phobia, Post Traumatic Stress Disorder or Complicated Grief (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).

• Subject has a history of schizophrenia or schizoaffective disorders, any history of psychotic symptoms or is on antipsychotic medication for the treatment of psychotic symptoms

• Subject has a history of eating disorders within five years of screening

• Subject has any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant at any time within six months prior to screening

• The participant is considered at significant risk for suicide during the study

• Subject has had electroconvulsive therapy in the current episode of depression

• Subject has had Transcranial Magnetic Stimulation or has received treatment with other experimental devices for the treatment of the current episode of depression

• Subject has received Vagus Nerve Stimulation at any time

• Dementia, delirium, amnestic, or other cognitive disorders

• There is a clinically significant abnormality on the screening physical examination

• Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation

• Known history or current episode of:

--Uncontrolled hypertension, Recent myocardial infarction (within one year) or a history of more than one myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris

• Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past two years.

• Lab abnormalities are present

• History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months prior to screening

• Hisotry of hyperthyroidism which was treated (medically or sugically) less than six months prior to screening

• Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with the interpretation of study results

• History of positive screening urine test for drugs of abuse

• Patient with any non-removable stimulation device such as neurostimulators, pacemakers and cochlear implants

• Patients requiring treatment with excluded concomitant medications

• Patients who cannot be in a MRI

• Patients who are currently using a metal intrauterine device (IUD)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35205
2	Yale University	New Haven	Connecticut	United States	06511
3	Emory University	Atlanta	Georgia	United States	30322
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Mount Sinai School of Medecine	New York	New York	United States	10029
6	University of Texas Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute of Mental Health (NIMH)
• Yale University
• Icahn School of Medicine at Mount Sinai
• University of Texas Southwestern Medical Center
• University of Alabama at Birmingham
• Emory University

Investigators

• Principal Investigator: Dan Iosifescu, MD, Mount Sinai School of Medecine
• Principal Investigator: Gerald Sanacora, MD, Yale University
• Principal Investigator: Madhukar Trivedi, MD, University of Texas
• Principal Investigator: Maurizio Fava, MD, Massachusetts General Hospital (Coordinating Center)
• Principal Investigator: Mark Rapaport, MD, Emory University
• Principal Investigator: Richard Shelton, MD, Univsity of Alabama at Birmingham
• Principal Investigator: George I Papakostas, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Fava, MD, Overall Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01654796
• Other Study ID Numbers: 2012P001233
• First Posted: Aug 1, 2012
• Last Update Posted: Sep 5, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Maurizio Fava, MD, Overall Principal Investigator, Massachusetts General Hospital: Depression; Treatment Resistant Depression
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant

Study Results

Participant Flow

Pre-assignment Detail	Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data. Adverse events are reported for all 85 subjects.

Arm/Group Title	Low Field Magnetic Stimulation	Sham (LFMS)	Sham LFMS First, Then Active LFMS
Arm/Group Description	Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.	Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.	Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
Period Title: Overall Study
STARTED	26	29	29
COMPLETED	25	26	28
NOT COMPLETED	1	3	1

Baseline Characteristics

Arm/Group Title	Low Field Magnetic Stimulation	Sham (LFMS)	Crossover Arm	Total
Arm/Group Description	Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.	Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.	Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.	Total of all reporting groups
Overall Participants	26	29	29	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.9 (14.8)	50.7 (10)	46.3 (14.6)	48.3 (13.3)
Sex: Female, Male (Count of Participants)
Female	15 57.7%	17 58.6%	15 51.7%	47 56%
Male	11 42.3%	12 41.4%	14 48.3%	37 44%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.8%	1 3.4%	0 0%	2 2.4%
Not Hispanic or Latino	25 96.2%	28 96.6%	29 100%	82 97.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	3 10.3%	0 0%	3 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 23.1%	6 20.7%	3 10.3%	15 17.9%
White	20 76.9%	19 65.5%	25 86.2%	64 76.2%
More than one race	0 0%	1 3.4%	1 3.4%	2 2.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Hamilton Rating Scale for Depression - 6 Items
Description	The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.
Time Frame	Baseline and 48 hours after initiating treatment

Outcome Measure Data

Analysis Population Description

Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.

Arm/Group Title	Phase 1 Active LFMS	Phase 1 Sham LFMS	Phase 2 Active LFMS	Phase 2 Sham LFMS
Arm/Group Description	Participants in this group receive Active LFMS treatment for 2 days in Phase 1.	Participants in this group received Sham LFMS treatment for 2 days in Phase 1.	Participants in this group received Active LFMS treatment for 2 days in Phase 2.	Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
Measure Participants	26	58	18	21
Baseline	11.7 (2.2)	11.3 (2.1)	10.9 (2.2)	9.4 (2.3)
End of Phase	8.8 (2.5)	8.1 (3.7)	9.6 (3.9)	8.0 (3.7)
Score Change	-2.8 (2.5)	-3.2 (3.3)	-1.3 (3.7)	-1.5 (2.4)

Adverse Events

Adverse Event Reporting Description	The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
Arm/Group Title	Low Field Magnetic Stimulation		Sham (LFMS)		Crossover Arm
Arm/Group Description	Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.		Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.		Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
All Cause Mortality
	Low Field Magnetic Stimulation		Sham (LFMS)		Crossover Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Low Field Magnetic Stimulation		Sham (LFMS)		Crossover Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Low Field Magnetic Stimulation		Sham (LFMS)		Crossover Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/27 (81.5%)		18/29 (62.1%)		20/29 (69%)
Cardiac disorders
Palpitations	0/27 (0%)	0	1/29 (3.4%)	1	1/29 (3.4%)	2
Electrocardiogram Abnormal	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Heart Rate Increased	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Tachycardia	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Ventricular Extrasystoles	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Ear and labyrinth disorders
Tinnitus	1/27 (3.7%)	1	0/29 (0%)	0	1/29 (3.4%)	1
Endocrine disorders
Hyperlycemia	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Hypoglycemia	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Parathyroid Tumor Benign	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Eye disorders
Myodesopsia	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Vision Blurred	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Gastrointestinal disorders
Diarrhea	1/27 (3.7%)	1	2/29 (6.9%)	2	1/29 (3.4%)	1
Nausea	1/27 (3.7%)	1	1/29 (3.4%)	1	2/29 (6.9%)	2
Constipation	0/27 (0%)	0	3/29 (10.3%)	3	0/29 (0%)	0
Dry Mouth	1/27 (3.7%)	1	1/29 (3.4%)	1	1/29 (3.4%)	1
Dyspepsia	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Gastrointestinal Disorder	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Vomiting	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
General disorders
Abdominal Discomfort	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Abdominal Pain Lower	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Decreased Appetite	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Dehydration	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Drooling	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Libido Decreased	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Orgasm Abnormal	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Sinus Congestion	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Sinus Headache	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Tension	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Weight Decreased	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Weight Increased	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Musculoskeletal and connective tissue disorders
Back Pain	1/27 (3.7%)	1	1/29 (3.4%)	1	1/29 (3.4%)	1
Bruxism	0/27 (0%)	0	2/29 (6.9%)	2	0/29 (0%)	0
Muscle Twitching	0/27 (0%)	0	0/29 (0%)	0	2/29 (6.9%)	2
Toothache	0/27 (0%)	0	1/29 (3.4%)	1	1/29 (3.4%)	1
Medial Tibial Stress Syndrome	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Muscle Spasms	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Muscle Tightness	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Tooth Fracture	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Nervous system disorders
Headache	6/27 (22.2%)	9	10/29 (34.5%)	17	5/29 (17.2%)	7
Paraesthesia	0/27 (0%)	0	1/29 (3.4%)	3	2/29 (6.9%)	2
Myalgia	1/27 (3.7%)	1	0/29 (0%)	0	2/29 (6.9%)	3
Aphasia	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Dysgeusia	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Hiccups	0/27 (0%)	0	1/29 (3.4%)	2	0/29 (0%)	0
Migraine	0/27 (0%)	0	1/29 (3.4%)	1	1/29 (3.4%)	1
Pain in Extremity	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Asthenia	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Hypoaesthesia	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Tremor	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Psychiatric disorders
Irritability	2/27 (7.4%)	2	2/29 (6.9%)	2	3/29 (10.3%)	3
Insomnia	0/27 (0%)	0	2/29 (6.9%)	2	4/29 (13.8%)	4
Disturbance in Attention	2/27 (7.4%)	2	2/29 (6.9%)	2	1/29 (3.4%)	1
Somnolence	2/27 (7.4%)	2	1/29 (3.4%)	1	1/29 (3.4%)	2
Memory Impairment	2/27 (7.4%)	2	1/29 (3.4%)	1	1/29 (3.4%)	1
Sleep Disorder	1/27 (3.7%)	2	1/29 (3.4%)	1	1/29 (3.4%)	1
Abnormal Dreams	2/27 (7.4%)	2	0/29 (0%)	0	1/29 (3.4%)	1
Anxiety	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Apathy	0/27 (0%)	0	1/29 (3.4%)	1	1/29 (3.4%)	1
Fatigue	0/27 (0%)	0	1/29 (3.4%)	1	1/29 (3.4%)	1
Psychomotor Hyperactivity	1/27 (3.7%)	1	1/29 (3.4%)	1	0/29 (0%)	0
Confusional State	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Nightmare	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Obsessive-Compulsive Disorder	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Restlessness	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0
Renal and urinary disorders
Pollakiuria	2/27 (7.4%)	2	1/29 (3.4%)	1	0/29 (0%)	0
Hypokalemia	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection	2/27 (7.4%)	2	1/29 (3.4%)	1	2/29 (6.9%)	2
Nasopharyngitis	2/27 (7.4%)	2	1/29 (3.4%)	1	0/29 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Flushing	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Rash	0/27 (0%)	0	0/29 (0%)	0	1/29 (3.4%)	1
Vascular disorders
Dizziness	1/27 (3.7%)	2	2/29 (6.9%)	4	2/29 (6.9%)	2
Blood Pressure Increased	0/27 (0%)	0	1/29 (3.4%)	4	1/29 (3.4%)	1
Hot Flush	4/27 (14.8%)	4	0/29 (0%)	0	0/29 (0%)	0
Presyncope	1/27 (3.7%)	1	0/29 (0%)	0	0/29 (0%)	0
Syncope	0/27 (0%)	0	1/29 (3.4%)	1	0/29 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.