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 STEP-BD Women's Studies
Though both men and women are affected by bipolar disorder, the treatment of women with this illness is of particular concern. For women, there is interest in how specific medications or therapies could affect reproductive health or pregnancy. A search for safe and effective treatment options for women with bipolar disorder is being carried out by the STEP-BD Women's Studies (SWS) program. Currently, three exciting new studies are being done to investigate several questions in the treatment of women inrolled in
STEP-BD.

The Relationship Between Valproate and Other Mood-Stabilizer Therapies to the Polycystic Ovarian Syndrome and Polycystic Ovarian Morphology in Women with Bipolar Disorder

Principal Investigator: Hadine Joffe, M.D.

This study will assess the relationship between use of mood-stabilizer medications and women's reproductive health, specifically polycystic ovarian syndrome (PCOS). Women between the ages of 18-45 enrolled in STEP-BD who are taking a mood stabilizer may be eligible for participation. Participation involves 2-3 brief visits to complete some questionnaires, a skin exam, a blood test and an optimal ultrasound procedure to look at the ovaries.

Participation in this study will benefit women by providing detailed information about their hormones, ovaries, and reproductive health. It is important for women to learn if they have the hormonal problem of PCOS because PCOS puts women at risk for infertility, diabetes, and possibly heart disease and cancer of the uterus. PCOS is also an illness that is treatable with medications. Additionally, participants will be reimbursed up to $80.00 for their time and effort in completing the tasks.


A Pilot Study of Omega-3 Fatty Acids in Women with Bipolar Disorder who are Planning Pregnancy

Principle Investigator: Lauren Marangell, M.D.

Many women with bipolar disorder who are planning to become pregnant think about stopping their medications. Sometimes this can be done with the careful supervision of a psychiatrist, but some times this is a bad idea. Medications for bipolar disorder should never be stopped without the psychiatrists’ advice and knowledge. Either way, it is best to plan ahead for pregnancy. For women who have decided with their STEP-BD psychiatrist to come off of standard medications in order to plan pregnancy, this study is ideal.

All participants will have six meetings with a STEP therapist to prepare for the unique stresses of pregnancy. Participants will also receive study capsules for up to one year. The capsules contain either placebo (an inactive substance) or an omega-3 fatty acid. Omega-3 fatty acids are not harmful for the fetus, and may help prevent relapses of symptoms in bipolar disorder, but this is not certain. All women will be carefully watched by the treatment team and taken off the study capsules if symptoms return.

This study will help us to understand the role of omega-3 fatty acids in pregnancy and more about pregnancy in bipolar disorder. Women in the STEP-BD study who are planning pregnancy should ask their doctors if they might be eligible for this important study.


Brain Levels of Lithium as a Predictor of Drug Response in Depressed Women with Rapid Cycling Bipolar Disorder: Pilot Study

Principal Investigator: Alan Mallinger, M.D.

The principal aim of this study is to determine the utility of lithium MR spectroscopy in predicting the course of illness in women with rapid cycling bipolar disorder. Use of this technique may inform researchers how to use lithium to greater advantage for this population. Eligible participants will be randomized to receive either lamotrigine or fluoxetine in addition to existing medications. They will complete two separate scans of the brain, using a method that is similar to an MRI procedure, 10 weeks apart. This procedure is non-invasive, and participants will be reimbursed $50 for each scan. This study is available at the Presbyterian University Hospital (Pittsburgh) STEP-BD site only.

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