Bipolar Research Studies

* Bipolar Disorder Study - Signs and Symptoms: Feeling down and depressed? Lost interest in your normal activities? Do you have uncontrollable mood swings, trouble sleeping, or difficulty concentrating? Do you experience highs and lows? If you or someone you know is experiencing any of these symptoms, you may be suffering from Bipolar Depression (also known as Manic Depression). Daniel D. Anderson, M.D., is conducting a research study for people with Bipolar Depression. If you qualify, you may be eligible to participate in a study testing the effectiveness of a research medication for the treatment of Bipolar Depression at no cost to you. If you would like additional information regarding this study and are between the ages of 18 and 75, please contact Alex Soltani at (310) 891-0106.


* GlaxoSmithKline (GSK) is sponsoring clinical research studies to evaluate the effectiveness of a medication for treating depression in patients with bipolar disorder. This medication is currently approved by the FDA for the maintenance treatment of bipolar disorder; however, less is known about its use for acute treatment of bipolar depression. Patients are randomly assigned to receive either the medication or a placebo for eight weeks. If eligible, patients will come to the clinic approximately once a week during the treatment phase of the study, and once more for a follow-up visit after the treatment. To be eligible, a patient must be at least 18 years old, experiencing depression, and have a diagnosis of bipolar disorder. There are no costs to the patient for study medication, study visits or study procedures. Participation is entirely voluntary and patients may withdraw from the study at any time for any reason. Visit www.BipolarDepressionStudy.com or www.Veritasmedicine.com (click bipolar disorder then find clinical trials).

* National Institute of Mental Health, Intramural Research Program, National Institutes of Health, Department of Health and Human Services. Looking for families with two or more siblings with bipolar illness. Diane Kazuba, toll-free, at 1-866-NIH-GENES (1-866-644-4363), or email kazubad@intra.nimh.nih.gov

* Adults with Bipolar Disorder and Depression - There are opportunities to participate in clinical trials exploring the research effects of novel therapeutics compared to placebo for the treatment of depression and bipolar disorder. Several of these trials look at treatment-resistant mood disorders. Volunteers over the age of 18 may be eligible. The studies are conducted at the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, in Bethesda, Maryland. Atendemos pacientes de hable hispana. Call 301-496-5645 or 1-866-627-6464 (TTY: 1-866-411-1010).

* Child and Adolescent Bipolar Disorder Study - The National Institute of Mental Health is seeking boys and girls ages 6 to 17 to participate in a study of bipolar disorder in children and adolescents. The study includes a five-day outpatient assessment and infrequent research follow-up visits over four years at the NIH Clinical Center in Bethesda, MD.
Participants must be: [list][*]In treatment with a psychiatrist for bipolar disorder [*]On stable medications for the first 6 weeks of the study [*]Able to fill out daily self-rating forms and cooperate with study procedures (including genetics studies, MRI, psychological testing, and others)[/list:u] A thorough evaluation at NIMH is provided free of charge. Travel and lodging expenses are paid for by NIMH. For more information, call 301-496-5645 (TTY: 1-866-411-1010).

* Children and Adolescents with Bipolar Disorder - The National Institute of Mental Health is conducting a study for treatment-resistant bipolar disorder.

Participants will receive: [list][*]Clinical and psychological assessments (including an inpatient assessment during which children will be withdrawn from medication)[*]Treatment with clozapine or placebo[*]Brain imaging (no radiation)[/list:u] Participants must: [list][*]Be between the ages of 8 to 17 with bipolar disorder[*]Not have done well on lithium, sodium valproate, carbamazepine, and at least one of the newer neuroleptics, as well as a combination of two of these medications[/list:u] All procedures are free of cost. Travel expenses are paid for. Call Robinder Bhangoo, M.D., or Ellen Leibenluft, M.D., at (301) 496-8381 or (TTY 1-866-411-1010).

*Adolescent Bipolar I Study: Participants are needed for a new adolescent Bipolar I Disorder research study of an atypical antipsychotic investigational medication known as Olanzapine. Teenagers must be between ages 13-17 and be diagnosed with Bipolar I Disorder, currently displaying an acute manic or mixed episode, or displaying the symptoms of Bipolar I Disorder. To learn more about participating in this research study, please visit www.teenmentalhealth.net or call toll free 1-866-874-2516.

*Bipolar Depression Research Study: This is a six-month Phase IV study comparing two marketed medications in the treatment of bipolar depression. If you have been diagnosed with Bipolar Depression (also called Manic Depression) and are currently depressed with symptoms such as: [list][*]Sadness [*]Loss of interest [*]Difficulty sleeping [*]Lack of energy [*]Changes in appetite[/list:u] You may be eligible to participate in an investigative medication research study comparing two active medications for the treatment of Bipolar depression. Participants should be 18 to 60 years old, currently depressed, have experienced at least one manic episode in their lifetime, and be in reasonably good health. Participants will have to undergo blood work, urine drug screening and EKG.
Study related tests and evaluation provided at no cost. $20 per visit provided for travel expenses. Call (888) 317-6262 for more information.

*Collaborative Genomic Study of Bipolar Disorder (Non-Treatment Study)
John Rice, Ph.D., at Washington University School of Medicine in St. Louis, in collaboration with 10 other sites across the United States, is conducting a study in an attempt to identify environmental and genetic markers that may be responsible for Bipolar 1 Disorder. A certificate of Confidentiality has been received from the federal government that ensures that all information will be strictly confidential. Data will be assigned a code number and the master list linking the code number and your identity will be kept separate from the research data. This is not a clinical drug-trial or treatment study. Participation will include: [list][*]A confidential personal interview and family history interview [*]Small blood sample for the genetic analysis phase of the research study [*]Monetary compensation for the time and effort will be provided[/list:u] If you are at least 18 years old and have a diagnosis of Bipolar 1 (severe form mania), you may be eligible to participate in our research. Participants who live to far from the School of Medicine may be interviewed by telephone. Blood samples may be drawn by local physicians and mailed back to our site if a personal visit from our staff is not possible.

Contact: Caroline E. Drain, M.H.S., Program Manager, Washington School of Medicine, Dept. of Psychiatry, 4625 Lindell Ave., Suite 200, St. Louis, MO 63108.
Telephone: (314) 286-1345 or 1-866-289-1378 (toll free).
Fax: (314) 454-0432
Email: drain@msnotes.wustl.edu
Web site: http://zork.wustl.edu/bipolar

*Treatment study for Children and Adolescents with Bipolar Disorder or Schizophrenia Spectrum Disorders: This study is an experimental drug study for children and adolescents ages 10-17 with Bipolar Disorder or schizophrenia spectrum disorders. This study will test the safety and efficacy of a research medication called ziprasidone (Geodon) in children and adolescents with these diagnoses. The study lasts up to 27 weeks.

BENEFITS OF PARTICIPATION [list][*]Up to 27 weeks of antipsychotic medication [*]A study-related psychiatric and medical evaluation conducted by staff at McLean Hospital in Belmont, MA [*]Reimbursement up to $275 for travel and time[/list:u] Inclusion Criteria [list][*]10-17 years old, male or female [*]Diagnosed with Bipolar Disorder or a schizophrenia spectrum disorder [*]Patients taking antidepressants or mood stabilizers must be willing to be weaned off them prior to starting study treatment, and stay off them for the first three weeks of treatment [*]Patients must also be weaned off any other antipsychotics before entering the study, and stay off them for the duration of the study [*]Patients must not be pregnant or abusing substances[/list:u] If you are interested in learning more about this study, please contact: Emily Gerstein, Study Coordinator Tel: 617-855-3694

* NIMH-funded multi-site study of recur rent, early onset depression is looking for families with bipolar illness. The first major depression must have occurred before age 30 in one sibling and before age 40 in the other.

Rush Presbyterian - St. Luke's Medical Center: Diana Marta, 1-312-563-2843, email: Diana_H_Marta@rush.edu
University of Iowa: Sandra Boutelle, 1-877-578-8845 (toll-free) or 1-319-353-4347, email: boutelle@blue.weeg.uiowa.edu
University of Pennsylvania: Kathleen Murphy-Eberenz, 1-877-407-9529 (toll-free) or 1-215-746-5153, email: kme@mail.med.upenn.edu
University of Pittsburgh: Wendy Zubenko, 1-877-485-7568 (toll-free) or 1-412-246-6530, email: wzubenko+@pitt.edu
Depression (Unipolar, Recurrent, etc.)

* Severe Depression Study - Feeling sad and depressed? Losing pleasure in engaging in daily activities? Difficulty concentrating or easily distracted? Suffering from low self-worth? If you or someone you know is experiencing any of these symptoms, you may be suffering from Severe Depression. Daniel D. Anderson, M.D., is conducting a research study for people with Severe Depression. If you qualify, you may be eligible to participate in a study testing the effectiveness of a research medication for the treatment of Severe Depression at no cost to you. If you would like additional information regarding this study and are between the ages of 18 and 75, please contact the office of Daniel D. Anderson, M.D., at (310) 891-0106.

* The Depression Research Clinic at Stanford University - The Stanford University Depression Research Clinic in the Department of Psychiatry and Behavioral Sciences is currently conducting several studies evaluating the effectiveness of new and investigational treatments for depression. If you are bothered by depression nearly every day, are 18 years or older, in good physical health, and are able to attend weekly appointments at Stanford between the hours of 8 a.m. and 5 p.m., Monday through Friday, you may be eligible. All of the studies involve an initial phone screen, during which time research staff will ask you questions to determine eligibility, explain the studies for which you may be eligible, and answer any questions that you may have. Participation is free and all calls are confidential. If you would like more information, please call the research study line at 650-723-8330.

* Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression - A large, 16 center, randomized, placebo controlled trial to evaluate the safety and effectiveness of transcranial magnetic stimulation (TMS), a non-medication, non-invasive outpatient procedure, is currently underway. This trial will test a TMS device to evaluate its safety and ability to improve mood in patients with major depression. Information from this trial will be submitted to the US Food and Drug Administration (FDA) to support clearance which will allow physicians to prescribe TMS to treat patients with symptoms of depression.

Inclusion Criteria: [list][*]Diagnosis of Major Depressive Disorder (MDD) [*]Age 18 – 70 years [*]Read and speak fluent English [*]Both males and females[/list:u] Exclusion Criteria: [list][*]Prior treatment with TMS [*]Metal objects in your head [*]Pregnancy or possible pregnancy [*]A diagnosis of psychosis, bipolar disorder, or OCD [*]Increased pressure in the brain for any reason [*]Intracardiac lines of any type [*]A diagnosis of a significant neurological disorder [*]A non-response to prior ECT[/list:u] Note: There are other less common factors which may prevent study enrollment.

For information regarding TMS, trial specifics and locations, visit www.neuronetics.com. Individuals interested in participating in this trial, please call 1-800-345-8707.

*Families Affected by Depression: Washington University School of Medicine in St. Louis Missouri, is part of an international research project that is attempting to identify the genetic and environmental factors that may be responsible for Major Depressive Disorder. New information from the human genome project will be used to guide scientists to the genes that may determine which family members develop depression while others do not. Identification of these susceptibility genes will revolutionize our understanding of the disorder and will guide the design of new drugs to treat or even prevent this debilitating condition. Dr. Allen Roses, Worldwide Director of Genetics at GlaxoSmithKline, who are sponsors of the study, said: “There is strong evidence that points to a genetic predisposition to unipolar depression. The information available from the sequencing of the human genome together with the data we gather from this study will provide an unprecedented level of understanding which GlaxoSmithKline can feed into its research and development program to help speed up the discovery of new medicines.” A trained research assistant will ask each participant a series of confidential questions that address a broad range of life experiences that may or may not have occurred and that family members may or may not have experienced. Relatives who live too far away to visit the School of Medicine may be interviewed by telephone. Participants will also be asked to give a small blood sample for DNA studies. Blood samples may be drawn by local physicians and mailed back to our site if a personal visit from our staff is not possible.

Study criteria: We are looking for families where two or more full siblings (either brothers and/or sisters), sharing the same mother and father: [list][*]have experienced two or more episodes of depression – treatment is not provided by this study and IS NOT required for participation [*]are at least 18 years of age at the time of enrollment [*]have no history of Mania (either a mild or severe type)[/list:u] Additional family members may also participate and it is our hope that a significant proportion of families will be composed of these additional members (e.g, parents and "other" siblings). Participation will take approximately two to four hours to complete and monetary compensation for time and travel will be provided. For more information, please call or email Caroline Drain, M.H.S. at (314) 286-1345, drainc@msnotes.wustl.edu or call toll-free at 1-888-292-1210 or visit our web-site at www.zork.wustl.edu/depression