|
|
|
|
|
Polycystic Ovarian Syndrome Study Mood stabilizers (such as lithium or Depakote) are a key component in the treatment of bipolar disorder. Therefore, potential side effects of these medications on women's reproductive health are of great importance. This study, the Polycystic Ovarian Syndrome Study (PCOS), plans to investigate the association of mood-stabilizer medications with ovarian changes and polycystic ovarian syndrome. Polycystic Ovarian Syndrome is a treatable disorder defined by a lack of ovulation, elevated levels of male hormones, and ovaries that become enlarged and have multiple cysts. The syndrome may result in the following: menstrual cycle irregularities, excessive hair growth, and acne. PCOS has other important health consequences, including an increased risk of diabetes, infertility, and possibly, cardiovascular disease and endometrial cancer. Evidence of a possible link between valproate (Depakote) use and PCOS has come from studies of women with epilepsy. We are conducting this important study because no research on such an association in women with bipolar disorder has been conducted. This study plans to enroll 524 women from those enrolled in the STEP-BD project at approximately 20 STEP-BD sites across the country. PCOS participants should be 18-45 years old, diagnosed with Bipolar Disorder, and not taking oral contraceptives. Participation in this study includes completion of questionnaires, one blood test, a skin examination for acne and hair growth, and an ultrasound examination (optional). By taking part in this study, you will receive an evaluation of your hormonal levels and ovaries, free of charge. More importantly, however, you will play a critical role in learning how women with bipolar disorder should be treated with medications in the future. A Pilot Study of Omega-3 Fatty Acids in Women with Bipolar Disorder who are Planning Pregnancy One of the most difficult problems for women with Bipolar Disorder is the lack of effective treatments that do not cause birth defects. Some women with Bipolar Disorder choose to stop using medications during pregnancy while trying to conceive. However, the return of mania or depression may be an even greater threat to the mother and the developing fetus. You may have heard of a type of oil, omega-3 fatty acids (a group of essential, polyunsaturated lipids) that are found in certain types of fish and plants. Omega-3 fatty acids do not cause birth defects and are needed for good fetal and infant development. While it is not known for certain, some studies suggest that omega-3 fatty acids may help prevent recurrence in bipolar disorder. The Omega-3 study is only for women with Bipolar Disorder who have decided to stop standard medication for the purposes of pregnancy. This study compares an omega-3 fatty acid (DHA) and placebo. The woman would begin with a slow discontinuation of standard medications (a six-week discontinuation period). The woman would be assigned to either the omega-3 or placebo treatment. Both groups will receive the "treatment" for up to one year. All study participants will be followed very closely during the entire study and will also receive 6 sessions of psychotherapy to help plan for the stresses of pregnancy. A total of 36 patients from those enrolled across all STEP-BD sites will participate in the first phase of this study. For patients who experience signs of clinical worsening during the study, appropriate standard care will be resumed. All participants must be 18 years of age or older, have Bipolar Disorder, Type I or II, and be of childbearing potential and wanting to become pregnant. There are no known serious adverse reactions to omega-3 (DHA). The most common adverse effect is mild gastrointestinal distress. The omega-3 (DHA) preparation is vegetarian and certified kosher by the Orthodox Union (OU). It is very important that women who are considering pregnancy understand that stopping standard mood stabilizers may be associated with an increased risk of episode recurrence. Women should only participate in this study if they have decided, in agreement with their doctor, to stop standard medications for the purpose of planning to become pregnant. This study is not recommending medication discontinuation, but rather, offers those women who choose medication discontinuation an option. DHA may or may not be an effective mood stabilizer for patients with bipolar disorder. The psychotherapy may help reduce the risk of relapse and may provide a way of developing better family relationships or better understanding of bipolar mood disorder. The public health significance of developing a mood stabilizer that does not cause birth defects is very important. However, no benefit is guaranteed. Patients interested in participating in this study should contact their STEP treating psychiatrist. We anticipate that the study will start in February 2001. Brain Levels of Lithium as a Predictor of Drug Response in Depressed Women with Rapid Cycling Bipolar Disorder Pilot Study Rapid Cycling is a specific type of Bipolar Disorder and accounts for 13-20% of all bipolar disorder cases. Approximately two-thirds of these people with rapid cycling are women. Rapid cycling bipolar disorder is difficult to treat and can lead to other significant health problems. Therefore, it is very important to develop better approaches to treatment. The main goal of this study is to determine how useful brain imaging (lithium MR spectroscopy (LiMRS)) is in predicting a course of treatment for rapid cycling bipolar disorder. LiMRS measures the level of lithium, a common treatment for women with bipolar disorder, in the brain. The LiMRS study hopes to determine if lithium levels in the brain are related to how well bipolar patients who are depressed respond to treatment with lithium. This study will also look to see if lithium levels in the brain are related to protecting patients from episodes of mania or rapid cycling. Also, the study wants to find if adding additional treatments with fluoxetine or lamotrigine can affect brain lithium levels. The individuals who participate in this study will be non-pregnant women with a past history of rapid cycling bipolar disorder who are enrolled in STEP-BD and have been on lithium treatment for at least 3 weeks, and who are experiencing a current episode of depression. Study participants will be randomly assigned to an add-on treatment of either fluoxetine or lamotrigine for an 8-week period. Throughout this time, lithium treatment will continue. All participants will be monitored closely by research staff members who are masked (not be allowed to know) to which add-on treatment the person is assigned. Mood ratings will be performed at an initial visit and then each week for the 8-week period. In addition, brain imaging to look at lithium levels will be done at the start of the study, and again after 6 weeks of the additional treatment. There will be 40 total participants from the Massachusetts General Hospital and Pittsburgh STEP-BD sites. Back to top Home | Public | Research | Our Goals | Who We Are | Frequently Asked Questions Scientific Advisory Board | Focus on Women
|
