Yale School of Medicine

Major Department or Entity

Women's Health Research

Women's Health
Research at Yale
PO Box 208091
New Haven, CT 06520-8091
Tel: 203.764.6600
Fax: 203.764.6609
whresearch@yale.edu

Clinical Trials

Women’s Health Research at Yale supports clinical trials that are generating new and useful scientific knowledge about women's health and gender differences.  The following clinical trials are currently recruiting subjects.

  • Diet, Weight Loss and Cardiovascular Health
    This study is investigating the longitudinal impact of diet and/or exercise-induced weight loss on metabolic markers of cardiovascular risk.  More information
    [CLOSE ]

    The “intervention group” is closed to enrollment. Dr. Barbara Gulanski is currently seeking healthy, normal weight, non-smoking, post-menopausal women between 40 and 65 years of age as a “comparison group” for her research on cardiovascular health. Study participants must not be taking estrogen or cholesterol lowering medications.  Two visits to the Yale New Haven Hospital General Clinical Research Center for a variety of non-invasive tests are required. Results shared with participants. Participants are not compensated. Interested volunteers may contact Laurie at (203) 764-6623. (Protocol # 25094)

    [CLOSE]
  • Protein Intake and Bone Health
    Given emerging concerns about side effects from drug therapies for low bone mass (Osteoporosis), nutritional approaches to bone health beyond calcium and vitamin D are urgently needed.  More information
    [CLOSE ]

    Osteoporosis and low bone mineral density affect almost 44 million Americans over the age of 50 years, most of whom are women, and this number is expected to grow to 52 million by the year 2010. Dr. Karl Insogna at the Yale School of Medicine is investigating the possible benefit of a protein supplement on bone health in postmenopausal women.  We are asking healthy women over the age of 60, who naturally consume a diet low to moderate in protein, to participate in our study, which will begin in early 2007.  Study participants must not have osteoporosis or other bone disease and may not be taking estrogen or other medications to prevent bone loss.  After an initial screening examination, bone density test and blood work, eligible participants will be randomized to take either a 40-gram protein or placebo supplement daily for 18 months.  The protein or placebo supplement will be incorporated into your usual diet and it is expected that your weight will remain stable over the course of the study.  Study visits will occur every 3 months and study participants can choose to be followed at either of the two study sites for this trial which are, the Yale University Clinical Research Center in New Haven, CT and the University of Connecticut Health Center in Farmington, CT.  During the course of this trial participants will receive free bone density testing, nutritional counseling and health screening.  If you are interested, please call the Recruitment Center toll-free at 1-866-846-2849.  Help us find alternative, safe and effective therapies for the prevention of osteoporosis!  (Protocol # 0610001951)

    [CLOSE]
  • Treatment of Premenstrual Symptoms
    This is a Premenstrual Symptoms (PMS) Treatment trial comparing the FDA-approved medication Serafem to Calcium supplements, both as compared to placebo, for the treatment of moderate symptoms occurring the week before menstruation. More information
    [CLOSE ]

    Women chart their symptoms for one menstrual cycle to confirm a diagnosis of moderate Premenstrual Syndrome. Participants are asked to participate in one of the treatment conditions (Serafem, Calcium or placebo); all participants receive Calcium at some point during the 7-month long study. Typical PMS symptoms could include: fluxuations in mood, such as sadness, anger, anxiety and/or irritability; difficulty concentrating or making decisions; disruption in sleep or appetite; functional impairment in work/home/relationship domains; physical symptoms. Treatment services are free and confidential and available in English and Spanish in our New Haven, CT office. Participants are not compensated. Kimberly Yonkers, M.D. is the Principal Investigator for this trial. Please call (203)764-6621 to participate or visit our website at www.researchforher.com for more information.

    [CLOSE]
  • Effects of estrogen replacement on heart health in recently postmenopausal women
    Yale is one of 8 national study centers now recruiting for this 4-year study focusing on the effects of hormone therapy on the progression of heart disease and other health problems in recently postmenopausal women. More information
    [CLOSE ]

    Healthy women age 42-58, who have not had their periods for at least 6 months and less than 3 years, will be randomly assigned to hormone therapy or placebo. Site Principal Investigator: Hugh Taylor, M.D.; GCRC Principal Investigator: Barbara Gulanski, M.D., M.P.H. Subjects will be compensated for their participation. Please call Diane at (203) 785-4739. (Protocol # 27022) (KEEPS: Kronos Early Estrogen Prevention Study)

    [CLOSE]
  • Exploring the Link between Mental Stress and Heart Disease in Women
    This project seeks to study women with coronary artery disease and explore the link between mental stress and heart disease.  More information
    [CLOSE ]

    This project seeks women with coronary artery disease to participate in either of two studies which will include testing of heart and brain function using noninvasive imaging equipment. Participants will receive financial compensation. Principal Investigator: Robert Soufer, M.D. Please call Christine Earley at (203) 932-5711, Ext. 3332; or Luisa Sheehan at (203) 932-5711, Ext. 2839 (Yale University School of Medicine HIC Protocol #s: 9256 & 22874; VA Connecticut Healthcare System HSS Protocol #s: RS0017 & RS0018)

    [CLOSE]
  • Finding Predictors of Depression and Response to Treatment
    The current study uses a non-invasive brain imaging technique called magnetic resonance spectroscopy (MRS) to investigate whether GABA can be used as a marker for specific subtypes of depression, and whether GABA levels can be used to predict response to specific antidepressant treatments.   More information
    [CLOSE ]

    Previous work by our group has demonstrated abnormally low levels of the brain chemical (gamma-amino butyric acid or GABA) in depressed individuals. MRS uses magnetic fields and radio waves, similar to magnetic resonance imaging (MRI). But, rather than visualizing the brain, MRS is able to measure the levels of several chemicals and neurotransmitters in the brain. GABA levels in depressed patients are assessed before and after various kinds of treatment for depression, such as cognitive behavioral therapy (see below) or different kinds of medications, to determine whether GABA levels are abnormal in depression and if different treatments have an effect on this chemical. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 12812)

    [CLOSE]
  • Cognitive Behavioral Therapy (CBT) in the Treatment of Depression
    Cognitive behavioral therapy (CBT) is an effective, short-term, structured form of psychotherapy that focuses on alleviating negative ways of thinking.  More information
    [CLOSE ]

    Depressed individuals often have negative opinions of themselves and tend to have negative interpretations of events as well as negative expectations for the future. These kinds of thought patterns increase an individual's risk of developing or maintaining depression when they experience stressful life events. The use of CBT to alter these cognitive patterns has proven effective in the treatment of depression. This study provides twelve weeks of CBT for the treatment of depression at no cost. It also uses a non-invasive technique to measure levels of neurotransmitters in the brain before and after treatment by obtaining magnetic resonance spectroscopy measures (MRS - see above). These MRS measures, as well as other assessments in this study, may help us to understand which individuals are likely to respond to treatments such as cognitive behavioral therapy. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 26807)

    [CLOSE]
  • Cognitive Behavioral Therapy for Patients Receiving Electroconvulsive Therapy (ECT)
    This study develops a model of cognitive behavioral therapy (CBT – see above) specific for patients receiving Electroconvulsive therapy (ECT), an effective and rapidly acting treatment for depression.  More information
    [CLOSE]

    ECT provides benefit for many individuals suffering from severe medication-resistant depression, but many patients whose depression improves following ECT experience a relapse of symptoms within the six months following their treatment. This study hopes to determine if combining these two treatments could increase the benefits of ECT and prolong the period of remission from depression brought about by ECT. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 12500)

    [CLOSE]
  • Cognitive Behavioral Therapy in the Treatment of Panic Disorder and Generalized Anxiety Disorder
    Cognitive Behavioral Therapy (CBT) is a form of talk therapy that has been very effective in the treatment of anxiety disorders, such as Panic Disorder and Generalized Anxiety Disorder (GAD). More information
    [CLOSE]

    Participants in this study who suffer from panic disorder or GAD will receive 13-18 weeks of CBT targeted at their anxiety disorder, free of cost. They will also undergo measures of Magnetic Resonance Spectroscopy (MRS - see above) to measure levels of certain neurotransmitters in the brain. These MRS measures may help us to understand which individuals are likely to respond to treatments such as cognitive behavioral therapy and what effect this type of therapy may have on these brain chemicals. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 25397)

    [CLOSE]
  • The Treatment of Refractory Depression
    Recent studies in our clinic and at the National Institutes of Mental Health suggest that the medication Riluzole (Rilutek®) may have antidepressant properties. Individuals who are currently taking antidepressant medications but who are still experiencing some symptoms of their depression may be helped by the addition of Riluzole to their existing medications.  More information
    [CLOSE ]

    Subjects in this study will receive 12 weeks of Riluzole treatment added on to their existing medications and will meet weekly with a psychiatrist in the clinic in order to better understand the effects of this novel treatment on the symptoms of depression. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 15638)

    [CLOSE]
  • Use of a Novel Antidepressant Treatment
    This study examines the effects that a brief novel treatment, with a drug called a glutamate (NMDA) antagonist, may have on the symptoms of depression and on different neurotransmitters in the brain.  More information
    [CLOSE ]

    Participants will receive several measures of Magnetic Resonance Spectroscopy (MRS - see above) to assess neurotransmitter levels both before and after a short dose of this novel treatment. Following this brief trial, participants will also receive 6 weeks of treatment with a serotonin reuptake inhibitor (SSRI) free of charge. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131 or email gerard.sanacora@yale.edu. (Yale University School of Medicine HIC Protocol # HIC# 26997)

    [CLOSE]
  • Exploring Genes Related to Depression
    Individuals participating in any of the six Yale Depression Research Program protocols described above may also choose to donate a sample of DNA or RNA for genetic analysis.  More information
    [CLOSE]

    These genetic studies could help in the understanding of the genes that contribute to the development of depression [HIC # 25410] and may uncover how the expression of these genes might predict response to antidepressant treatment. Principal Investigator: Gerard Sanacora, M.D., Ph.D. Call the Yale Depression Research Program at (203) 764-9131)

    [CLOSE]
  • Yale Mood Disorders Research Program
    The Yale Mood Disorders Research Program (MDRP) is dedicated to understanding the science of mood disorders, such as bipolar disorder (manic-depressive illness), depression and other mood disorders. More information
    [CLOSE]

    The MDRP brings together a multi-disciplinary group of scientists who use a wide variety of research methods in a highly collaborative research effort to study the genetic and environmental factors that contribute to mood disorders, and how these factors interact to affect the brain and cause the specific symptoms associated with these disorders.

    In ongoing research, MDRP scientists are working towards the development of biological markers that can help to determine if someone has a mood disorder, and if they do, what treatment might be most beneficial to them. We hope that these research efforts will lead to new and improved methods for the prevention, early detection and treatment of mood disorders. - MDRP Director, Hilary P. Blumberg, M.D.
    For more information on clinical trials, visit the mood disorder webpage: www.mood.yale.edu

    [CLOSE]
  • Predicting Relapse in Smokers with & without PTSD
    This study aims to identify stress hormone changes that influence success with smoking cessation in people with or without posttraumatic stress disorder (PTSD). More information
    [CLOSE ]

    We are seeking healthy adults between 18 and 55 years of age, who regularly smoke at least ½ pack of cigarettes a day, and who wish to quit smoking. Participants must be medically healthy and not dependent on alcohol or drugs. No medications can be taken during the study. If eligible for our study, participants will join a 4-week smoking cessation study and meet with a study coordinator for supportive therapy and advice on quitting and maintaining smoking abstinence. First week includes daily appointments, support and increasing payments to reward success. Second week includes three appointments, telephone support and payment for study visits. During third and fourth weeks, two follow-up appointments and telephone support if desired. Participants can earn up to $640 for attending all study visits and maintaining abstinence from smoking. Principal Investigator: Ann Rasmusson, M.D. Please call Eleni Dimoulas, Ph.D. at (203) 932-5711, extension 5015. (Yale University School of Medicine HIC Protocol # HIC# 19974; VA Connecticut Healthcare System HSS Protocol #: AR0020)

    [CLOSE]
  • Survey: Mothers as Individuals
    Mothers are central to their children's well being; therefore understanding mothers' major areas of need, and addressing these needs, is critical to promote positive youth development. More information
    [CLOSE ]

    Suniya S. Luthar, Ph.D., Professor of Clinical and Developmental Psychology, Teachers College, Columbia University is examining how mothers feel not only as parents but also as thinking, feeling and working individuals. This survey will help explore how mothers feel about their different roles not only as a mother, but also as a spouse, as a friend and an individual with various hopes and fears and how they cope with the challenges of balancing multiple roles. On average the survey takes 30-35 minutes to complete. It will be completely anonymous, such that there are no questions that will identify or link the data to any individual. Visit: http://www.momsaspeople.com/ Results of the survey will be compiled and posted on the web site. (IRB # 07-006)

    [CLOSE]
  • Selegiline for Smoking Cessation
    This project is a smoking cessation study to examine: (1) whether the FDA-approved medication selegiline (L-deprenyl, Eldepryl®) can be helpful for smoking cessation and (2) whether there are gender differences in the ability of selegiline to aid smokers. More information
    [CLOSE ]

    This study is for adults (ages 18-75) who are currently interested in quitting smoking. Participants in this 9 week trial will be randomly assigned to receive either selegiline or placebo. All participants will receive brief weekly individual counseling for smoking cessation and be asked to fill out research questionnaires. Subjects will be compensated for their participation. Principal Investigator: Marc N. Potenza, M.D., Ph.D. Please contact Erin at (203) 974-STOP (203-974-7867) or visit http://prism.yale.edu. (Protocol #26091)

    [CLOSE]
  • Menstrual Cycle Brain Imaging Studies
    Women with experience premenstrual dysphoric disorder (PMDD) undergo brain imaging once in the follicular phase and once in the luteal phase of the menstrual cycle before, during and after treatment with the serotonin reuptake inhibitor fluoxetine (Prozac®). More information
  • MoTHERS Study
    The goal of the Mothers Testing Hormonal Effects on Resonance Spectroscopy Study (MoTHERS Study) seeks to determine the impact that pregnancy and childbirth-related changes in hormones have on a particular brain chemical called gamma-aminobutyric acid (GABA).  
    More information
  • Impact of Nicotine on Menstrual Cycle-Related Changes in Brain GABA
    It is well known that women have a more difficult time stopping smoking than men. The goal of the Sex, GABA and Nicotine Study is to examine sex and menstrual cycle phase effects on brain GABA in female and male smokers.  
    More information
  • Medication Treatment Trial of Atomoxetine in Menopausal Women
    The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the mild to moderate cognitive disturbances frequently experienced by women during the menopause transition (ages 40-60) More information