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MOOD DISORDERS PROGRAM

at University Hospitals Case Medical Center

 

Clinical Trials & Research Projects


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Listed below you will find information on our current studies. Please contact us for additional information. Each study has eligibility criteria associated with it, and therefore you may or may not be eligible for enrollment.


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.


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: Keming Gao, MD, PhD / Keming.Gao@UHhospitals.org

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Quetiapine XR Monotherapy in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression with or without Substance Use Disorder

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).

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: Mary Beth Serrano/216.844.2817/Marybeth.Serrano@UHhospitals.org or Keming Gao/216.844.2865/Keming.Gao@UHhospitals.org

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Lithium in Moderate Use Doses for Bipolar Disorder (LiTMUS): A Randomized Controlled Effectiveness Trial

Gender & Age: Women & Men, ages 18 & older

Diagnosis: Bipolar Disorder (type I or II), currently experiencing a mood episode (depression, mania, hypomania, or a mixed state)

Medications: Optimized Treatment (OPT) versus OPT plus Lithium

Study Details: Up to 6 months long, visits are once every 2 weeks for the first 2 months and then monthly thereafter.

Contact: Carla Caonroy at 216.844.2871 or Carla.Conroy@UHhospitals.org


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 16 & 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: 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: Prashant Gajwani, MD

Gender & Age: Women & Men, ages 16 & 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.

Medications: Patients decide on their medications (treatment as usual), and at enrollment are assigned to one of two groups (VNS or non-VNS) depending on whether they have decided to have VNS implanted or not.  No study interventions are required in this Registry.

Study Details: Either 2 or 5 years long, visits are typically once every 3 months for the first year, and then once every 6 months.

Contact: 216.844.2863


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.