Clinical Studies for Psychiatry

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Title: Investigating Electrophysiological Markers for Depressive Rumination as Noninvasive Brain Stimulation (NIBS) Treatment Targets
Brief Title: FLEX Rumination
Brief Summary: By participating, you will help us investigate brain activity patterns associated with cognitive flexibility, a process which allows humans to switch tasks or perspectives. An additional, optional part of this study also seeks to evaluate the potential of non-invasive brain stimulation as a tool to alter brain activity patterns, with the goal of reducing depressive rumination and suicidal ideation. We are looking for individuals with recent (6 months) diagnosis of major depressive disorder or persistent depressive disorder, and healthy volunteers
For info regarding 2024P000910 please contact Ling-Yu Huang, PhD at 617-754-1259 or lhuang11@bidmc.harvard.edu
 
Title: Real time neurofeedback, its neurotransmitter underpinnings, and therapeutic effects, in clinical high risk individuals (CHR)
Brief Title: Neurofeedback and therapeutic effects in CHR
Brief Summary: The goal of this trial is to test whether fMRI based neurofeedback from default mode network (DMN) will reduce DMN hyperconnectivity in clinical high risk individuals, which will lead to reductions in clinical symptoms and improve cognitive performance.
For info regarding 2024P000177 please contact William Stone at 617-754-1235 or wstone@bidmc.harvard.edu
 
Title: Psychiatric Screening Repository: Data Collection for Mental Health
Brief Title: Psychiatric Screening Repository
Brief Summary: This study aims to assess changes in thinking, mood, or behavior through a semi-structured clinical interview using well-established mental health research tools. Your data will be securely stored and may be used with your permission for other research studies. The analysis of this information will help us better understand mental health challenges in adults aged 18-65 for improved diagnoses and treatment
For info regarding 2023P000390 please contact Paolo Lizano, MD at 617-754-1227 or plizano@bidmc.harvrd.edu
 
Title: Cerebellar Modulation of Cognition in Psychosis
Brief Title: TMS Processing Speed
Brief Summary: The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks). Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
For info regarding 2023C001134 please contact Roscoe Brady at 617-632-7933 or robrady@bidmc.harvard.edu
 
Title: Accelerated TMS for Psychosis
Brief Title: Accelerated TMS for Psychosis
Brief Summary: This study is to determine the tolerability and efficacy of an accelerated schedule of Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as schizophrenia.
For info regarding 2022P000689 please contact Roscoe Brady at 617-632-7933 or robrady@bidmc.harvard.edu
 
Title: Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
Brief Title: BICEPS
Brief Summary: The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.
For info regarding 2022P000622 please contact Lola Nedic at 617-863-0886 or lnedic@bidmc.harvard.edu
 
Title: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Brief Title: What the Nose Knows
Brief Summary: This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.
For info regarding 2022P000199 please contact Sunny Lee at 617-754-1203 or slee54@bidmc.harvard.edu
 
Title: The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
Brief Title: The Effect of Sleep Loss on Emotion
Brief Summary: The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. (i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
For info regarding 2022P000120 please contact Anthony Cunningham, PhD at (617)667-4702 or acunnin4@bidmc.harvard.edu
 
Title: A Pilot Study Utilizing Transcranial Direct Current Stimulation (tDCS) during Sleep to Enhance Slow Waves and Cognitive Function in Psychosis
Brief Title: tDCS Stimulation during Sleep: Pilot Study
Brief Summary: The Center for Sleep and Cognition at Beth Israel Deaconess Medical Center (BIDMC) is seeking patients with a diagnosis of Schizophrenia and healthy control participants for a sleep study involving 3 afternoon nap sessions. The main purpose of this study is to explore whether transcranial electrical stimulation (tES), a device that introduces a weak electrical current to the brain, can enhance physiological markers of sleep. We will examine if tES can influence brain electrical activity (measured using electroencephalogram (EEG) patterns) during sleep, and we will also explore if these changes in sleep are related to performance on variety of cognitive tasks pre- and post-nap.
For info regarding 2022P000117 please contact Anthony Cunningham, PhD at 617-667-4702 or acunnin4@bidmc.harvard.edu
 
Title: Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
Brief Title: Individualized Vocational and Education Support and Training
Brief Summary: The purpose of this study is to test the efficacy of InVEST (Individualized Vocational and Educational Support and Training) for CHR-P (clinical high risk for psychosis) to address specific role functioning difficulties associated with the CHR-P phase. Our specific goals are: 1. Part 1: Preliminary open trial of InVEST (n = 8) to collect preliminary feasibility and acceptability data by providing the intervention, administering assessments, and collecting focus group and self-report feedback from open trial participants. The open trial phase will help to refine recruitment approaches and to modify the treatment manual as needed. 2. Part 2: Preliminary randomized controlled trial of InVEST vs. Delayed InVEST (DI) to explore preliminary evidence of efficacy of InVEST vs. DI (n = 30). The investigators hope to gain understanding of the feasibility of InVEST and the study's assessment procedures, and to gain a preliminary understanding of the intervention's efficacy for functioning difficulties experienced by young people at CHR-P.
For info regarding 2021P000689 please contact Colette Potts at 617-754-1209 or ResponsetoRisk@bidmc.harvard.edu
 
Title: Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Brief Title: Family-Focused Therapy for Individuals at High Clinical Ris
Brief Summary: This study is being conducted by researchers from UCLA, BIDMC, and 5 other research sites to compare two different kinds of therapy for teenagers and young adults (ages 12-25) who may have experienced changes in their thinking or mood. The study seeks to determine whether family and individual counseling sessions help people to feel better and function better in school, work, and in relationships. It involves a full mental health evaluation, including diagnostic impressions and feedback, 6 months of one type of treatment for participant and involving their family members, and follow-up wellness/research check-ups for 18 months.
For info regarding 2020C000558 please contact Colette Potts at 617-754-1209 or ResponsetoRisk@bidmc.harvard.edu
 
Title: Retinal Layer, Microvascular and Electroretinographic Determinants of Early Course Psychosis
Brief Title: Retinal Determinants of Early Course Psychosis
Brief Summary: 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. 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.
For info regarding 2019P000815 please contact Brendan Stiltner at 617-754-1232 or bstiltne@bidmc.harvard.edu
 
Title: The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Brief Title: The Effect of Sleep Deprivation on Emotional Processing
Brief Summary: To further understand the impact of acute sleep deprivation and recovery sleep on the processing of emotional information the investigators will address and attempt to answer three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms are associated with these behavioral effects, and (iii) to explore the ability of recovery sleep to reverse the effects of sleep deprivation. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in emotion processing and regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to lengthen work days and increase social opportunities- such knowledge would be of practical importance for understanding the role of sleep in healthy emotional functioning, particular for individuals experiencing periods of increased stress and emotional distress (e.g., new parents, hospital staff, or combat troops).
For info regarding 2019P000062 please contact Robert Stickgold at 617-632-7926 or rstickgo@bidmc.harvard.edu
 
Title: The evolution of memories across wake and sleep
Brief Title: The evolution of memories across wake and sleep
Brief Summary: To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.
For info regarding 2016P000222 please contact Anthony Cunningham, PhD at 617-667-4702 or acunnin4@bidmc.harvard.edu