Ongoing Studies

A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)

PURPOSE: The purpose of this study is to examine the efficacy of lurasidone for improving cognition in patients with bipolar disorder types I and II who are not experiencing any symptoms of depression or mania, but are still experiencing cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.). Participants will go through cognitive testing throughout the study to determine efficacy of the medication.

This is the first study we have done looking at cognition in euthymic bipolar patients.

ELIGIBILITY: To participate in this study, you must be between the ages of 19 and 65. You may be eligible if you have bipolar disorder type I or II, and are currently stable on a mood stabilizer but still experiencing problems with cognition. Additional criteria will be assessed by a study doctor to determine your eligibility.

PRINCIPAL INVESTIGATOR: Joseph Calabrese, MD
RESEARCH COORDINATOR: Nicole Woods, BA; 216-844-2863; mdp@uhhospitals.org


Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults with Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study

PURPOSE: The overall goal of this study is to assess attentional biases, reward sensitivity, and cognitive control in patients with bipolar disorder with anxiety and/or substance use disorder comorbidity compared to matched controls who do not have any current comorbidities and to utilize this information to determine if eye-tracking technology has a realistic potential of aiding in the diagnosis and treatment of bipolar disorder.

ELIGIBILITY: To participate in this study, you must: be 18 years of age or older; either 1) meet criteria for Bipolar I or II Disorder and are currently depressed or euthymic or 2) have no current or past neurological or psychiatric diagnoses; are not currently taking any steroids, stimulants, or opioid pain killers. Additional criteria will be assessed by a study doctor to determine your eligibility.

PRINCIPAL INVESTIGATOR: Keming Gao, MD
RESEARCH COORDINATOR: Contact Nicole Jones, MS; 216-844-2862; mdp@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 Mood Disorders

PURPOSE: This research study is a Registry. A Registry is a collection of information from a set group of patients. No particular treatment is required. The registry will consist of a research database on your demographic information. The purpose of this Registry is to collect demographic information on a wide cross section of patients and to collect information that can be used for future research study recruitment.

ELIGIBILITY: Participants at least 18 years old are needed for a registry study. No particular treatment is required; the registry will consist of a research database of your demographic information, such as name, address, marital status, etc., that can be used for future research study recruitment. If you live in the Cleveland, OH area and are interesting in learning about research opportunities within the Department of Psychiatry at University Hospitals Cleveland Medical Center, you may be eligible. Participants can enroll over the phone or in person. Enrollment will take approximately 30 minutes.

PRINCIPAL INVESTIGATOR: Joseph Calabrese, MD
RESEARCH COORDINATOR: Contact Nicole Jones, MS; 216-844-2862; mdp@uhhospitals.org


Risk and Resilience Factors for Combat-Related Posttraumatic Psychopathology and Post Combat Adjustment

The Ohio Army National Guard Mental Health Initiative (OHARNG-MHI) began in 2008 to evaluate the relationships between resilience and risk factors of developing PTSD and other mental illness, and follows soldiers in the Ohio National Guard longitudinally, before, during, and after deployment. The "Risk and Resilience" 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 study is led by Dr. Joseph Calabrese and recently completed its eighth year of data collection. During that year, 1,140 service members completed their annual follow-up interviews. Since the project began in 2008, over 10,800 interviews have been completed with 3,841 Ohio National Guard members.

Thus far, the project has been able to provide the Ohio National Guard and the community with study related results that will ultimately benefit servicemen and their families. It has been found that: 1) the most common reason individuals stay in the guard is to serve their country, 2) post-deployment social support is an essential factor in the prevention of post-traumatic stress disorder and 3) depression and post-traumatic stress disorder increase the risk of new onset alcohol abuse, during or after deployment. With 35 published manuscripts and several manuscripts pending, the project was able to secure additional funding to continue data collection through May 2020.

If you are interested in receiving a list of our published manuscripts, along with a summary of the take home message of each, please e-mail Carla.Conroy@UHhospitals.org.

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