Ongoing Studies

Clozapine Study

Antipsychotic Response to Clozapine Treatment: A multi -site clinical trial supported by the National Institute of Mental Health.

Clozapine is a highly effective treatment for psychotic disorders, but we do not know at this time who are the patients that best respond to this treatment.  This study seeks to determine if there are differences as seen in tests of cognition and brain function in individuals treated with clozapine or risperidone. The results of this study will help doctors in choosing the right medications. Please contact Lola Nedic lnedic@bidmc.harvard.edu for more information.

BSNIP2

B-SNIP is a large-scale study, funded in 2007 by the National Institute of Mental Health. Schizophrenia and bipolar disorder both "run in families" although how they are inherited and which genes and environmental factors are the most relevant are not well understood. Neither is it clear how these factors affect brain structure and function, personality or cognitive abilities.The purpose of the B-SNIP study is to discover how the risk for schizophrenia and bipolar disorder is transmitted in families, to identify the most important risk genes and to measure the other factors listed above. Because the study is interested in measuring risk for the illnesses, we are as interested in assessing close family members as we are in examining people with the actual disorder.In order to do this, several thousand people will be recruited at fives sites throughout the United States, in Hartford/New Haven, CT, Athens, GA, Chicago, IL, Dallas, TX and Boston, MA. The study will assess people with schizophrenia, schizo-affective disorder, or bipolar (manic-depressive) illness on a variety of biological and genetic measures that seem to be associated with risk for the disorder.

BICEPS

Brain Imaging and Cognitive Enhancement in Early Phase of Schizophrenia (BICEPS) is a study funded in 2012 by the National Institute of Mental Health.The purpose of the BICEPS study is to understand how psychotherapy treatments work in people with early phase of schizophrenia using state-of the art and safe brain imaging studies.In order to do this, people recently diagnosed with schizophrenia or schizoaffective disorder will be recruited at two sites, in Boston, MA and Pittsburgh, PA. These persons will receive either Cognitive Enhancement Therapy (CET) or Enriched Supportive Therapy (EST) for a period of 18 months and will be followed up to examine the effectiveness and brain mechanisms underlying these treatments.

Retinal Study

Schizophrenia is a chronic disorder and is among the most highly disabling diseases in all of medicine, impacting approximately 1.5% of the population. This study will use novel state-of-the-art Electroretinography (ERG), Optical Coherence Tomography (OCT) and angiography (OCTA) imaging to capture retinal biomarkers that inform pathophysiology and clinical outcome in early course schizophrenia and chronic psychosis. This study is expected to have an impact on the growing consensus in psychiatry and neuro-ophthalmology that the retina provides a window into the brain that can be useful for understanding brain pathophysiology and for developing biomarkers of illness progression and possibly treatment response.

CLUES

"CLUES" stand for: Cognition for Learning and for Understand Everyday Social Situations.CLUES is designed to help improve attention, thinking, memory, and social skills in young people ages 16-30, who are being treated at the CEDAR clinic. CLUES, an NIMH-funded study, is based on a program called Cognitive Enhancement Therapy, which was found to help people with certain psychiatric conditions and significantly improve their thinking, work, and social functioning.CLUES is individually tailored to focus on helping participants to identify and achieve specific goals that are important to them.

PARDIP

The PARDIP (Psychosis and Affective Research Domains and Intermediate Phenotypes) study is a multi-site NIMH-funded research collaboration that aims to observe and test the biomarkers for psychosis and affect dimensions across schizophrenia/bipolar disorders, and look further into genetics for these biomarkers.

SPARCS

SPARCS (Sleep, Psychosis, Associated Risk and Cognition Study) is a National Institute of Mental Health funded study investigating the effects of sleep on memory and brain activity in patients with early course psychosis, first-degree relatives, and healthy controls. It is specifically focused on examining the differences of brain activity during sleep and how these differences can affect memory and learning. Identifying these differences could give researchers and clinicians new pathways and methodologies for treatment and prevention.

Digital Relapse Prediction

Schizophrenia and depression are among the most disabling disorders in all of medicine. The costs to society are greater than nearly any other chronic health condition and the burden to patients and family members is of the greatest magnitude. Better measurement of patients lived experiences is critical to better understanding not only the mechanisms of these illnesses but also new opportunities to intervene in the future. Our team, with the help of an approved vendor, has built a novel platform app (Learn, Assess, Manage and Prevent “LAMP”) that syncs with a smartphone and captures physiology data. The goal of this study is to utilize LAMP to identify digital biomarkers of mental illness that will help us learn about what factors influence both recovery as well as relapse in patients with schizophrenia and depression. Learn more about the study here: https://www.digitalpsych.org/project/digital-relapse-prediction

Digital Medicine

Medication non-adherence remains the leading cause of relapse in serious mental illnesses such as depression, bipolar disorder, and schizophrenia. Predicting non-adherence, however, remains challenging. This study aims to create predictive models of medication non-adherence (or adherence) by using digital markers that identify high risk environmental triggers, times, and behavioral patterns that represent clinically critical situations for carefully monitoring and responding to digital medicine ingestion data. It offers the potential to build predictive models of medication adherence and non-adherence based on knowing a medication was taken and what were the environmental, social, physical activity, and cognitive states at that time. Learn more about the study here: https://www.digitalpsych.org/project/digital-medicine

Motivational Interviewing Studies

Researchers at BIDMC are studying whether training in communication strategies can help parents and others (partners, siblings, friends, grandparents, or roommates) to address mental health and behavioral concerns with their children or other loved ones in a way that encourages healthy changes. Potential benefits include better communication skills. Please visit MILOstudy.com or contact mistudy@bidmc.harvard.edu or call/text (617) 982-3441 for more information.