| Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Gender & Age: Women & Men, ages 18-70
Diagnosis: Individuals with bipolar disorder who are currently experiencing depression and who also meet criteria for metabolic syndrome** or insulin resistance
Medications: All participants will receive pioglitazone, an FDA approved medication for the treatment of high blood sugar
Study Details: This study is designed to test whether pioglitazone reduces depressive symptoms. The study may last up to 20 weeks. Visits are typically once every week or every other week and last at least 1 hour long once enrolled. All potential participants will be screened for metabolic syndrome and insulin resistance at their initial study visit. All patients will receive active study medication (no placebo will be used). Participants cannot be suffering from heart failure.
Contact: David E. Kemp, MD @ 216.844.2863
**Metabolic Syndrome refers to a group of medical risk factors found in individuals who may be overweight, have high blood pressure or elevated cholesterol levels, and have family members with heart disease and/or diabetes. For more information on metabolic syndrome, click here.
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid with Metabolic Syndrome
Gender & Age: Women & Men, ages 18-70
Diagnosis: Major Depressive Disorder and Metabolic Syndrome**
Medications: All participants will be taking pioglitazone, an FDA approved medication for the treatment of high blood sugar.
Study Details: Study may last up to 24 weeks. Visits are typically once every week or every other week and last at least 1 hour long once enrolled. All potential participants will be screened for metabolic syndrome at their initial study visit. Participants cannot be suffering from Heart Failure.
Contact: David E. Kemp, MD @ 216.844.2863
**Metabolic Syndrome refers to a group of medical risk factors found in individuals that may be overweight, have high blood pressure or elevated cholesterol levels, and may have family members with heart disease and or diabetes. For more information on metabolic syndrome, click here. Mood & Metabolic Clinic Brochure | Metabolic Syndrome & Depresion Brochure
Quetiapine XR Monotherapy in the Treatment of Major Depressive Disorder with Comorbid Generalized Anxiety Disorder – PI: Keming Gao, MD, PhD
Gender & Age: Women & Men, ages 18-70
Diagnosis: Major Depressive Disorder, currently in a depressive episode with generalized anxiety
Medications:Patients will take Quetiapine XR or placebo (50-50 chance of getting placebo).
Study Details: The study will last for 8 weeks and the participant will be seen weekly for an hour. If the participant doesn’t do well during the study, he or she will discontinue the study. For inclusion into this study, the participant must not have tried Quetiapine more than 50 mg/day.
Contact:Liz Fein at 216.844.2863/ Elizabeth.Fein@UHhospitals.org
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Quetiapine XR monotherapy or adjunctive therapy to mood stabilizer in the treatment of comorbid generalized anxiety disorder in bipolar depression with or without substance use disorder – PI: Keming Gao, MD, PhD
Gender & Age: Women & Men, ages 18-70
Diagnosis: Bipolar Disorder (type I or II), currently in a depressive episode with generalized anxiety
Medications:Patients will take Quetiapine XR or placebo (50-50 chance of getting placebo). Open label lithium, depakote or lamictal may be continued during the duration of study participation.
Study Details: The study will last for 8 weeks and the participant will be seen weekly for a maximum of one hour. If the participant doesn’t do well during the study, he or she will discontinue the study. For inclusion into this study, the participant must not have tried Quetiapine more than 100 mg/day.
Contact:Liz Fein at 216.844.2863/ Elizabeth.Fein@UHhospitals.org
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A Long-Term, Observational, Multi-Center
Patient Outcome Registry to Collect Data in Patients for the
Scientific Study of Causes, Treatments and Illness Course of
Bipolar Disorders
Gender & Age: Women & Men, ages 18
& older
Diagnosis: Bipolar Disorder or Unipolar Major
Depression
Medications: No particular treatment is required
Study Details: The purpose of this Registry is to collect demographic information on a wide cross section of patients with a mood disorder, and to collect information that can be used for future research study recruitment. Participation in the Registry does not effect regular clinical treatment. We will inform participants of the option to enroll in other studies carried out as a part of the Center. We will also send the Center newsletter as it is published, approximately once every 3 months. We will contact Registry participants by email, mail, or telephone calls depending on preference.
Contact: Joseph Calabrese | 216.844.2863
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Long-Term, Observational, Multi-Center Patient Outcome Registry to Collect Data in Patients with Treatment Resistant Depression (TRD) – PI: Susan Kimmel, MD
Gender & Age: Women & Men, ages 18 & older
Diagnosis: Major Depressive Disorder (MDD) or Bipolar Disorder (type I or II), with Treatment Resistant Depression (TRD), defined as being in the current episode of depression for the past 2 years or longer, and having failed trials of at least 4 medications for depression.
Medications: With their clinical provider, patients decide on their medications. There are no treatment interventions within the Registry. At enrollment into the study, the participant is assigned to one of two groups (VNS or non-VNS) depending on whether they had previously decided to have VNS implanted.
Study Details: 5 years long, visits are typically once every 3 months for the first year, and then once every 6 months. Visits consist of completing questionnaires on following how the participant is doing. Compensation is provided.
Contact: Sarah Obral at 216.844.2869 | sarah.obral@UHhospitals.org
Risk and Resilience Factors for Combat-Related Posttraumatic
Psychopathology and Post Combat Adjustment
Since early 2005 Joseph Calabrese M.D. and the Center for Bipolar
Disorder have been working with Congresswoman Marcy Kaptur and
the Department of Defense on an exciting proposal entitled the
Kaptur DoD/DVA Mental Health Initiative. The general objective
of this initiative is to evaluate the relationships between
resilience and risk factors, both cross-sectionally and longitudinally,
before, during, and after treatment within the DVA. The primary
research project for this initiative was garnered through a
2006 Department of Defense allocation and is entitled “Risk
and Resilience Factors for Combat-Related Posttraumatic Psychopathology
and Post Combat Adjustment.
This primary project is designed to study the relationships
between 1) pre-existing mental illness/substance use disorders,
2) deployment to Operation Iraqi Freedom (OIF) or Operation
Enduring Freedom (OEF), and 3) post-deployment related mental
health and overall psychosocial adjustment. The proposed study
will evaluate several groups of the Ohio National Guard: those
deployed to OIF (Iraq, Kuwait, or Qatar), those deployed OEF
(Afghanistan), those deployed to other theaters (Bosnia, Turkey,
Uzbekistan, Kosovo, on a ship, or other), those deployed domestically,
and those not deployed. This project is designed to enroll up
to 3,000 members of the Ohio National Guard and Reserves beginning
in 2007/2008. Research visits will be conducted at time of enlistment,
90-180 days post-deployment, and then every 12 months for a
minimum of 10 years.
For more information on this ongoing research project, please
click here.
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