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37 recruiting in CT
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Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder

Generalized Anxiety Disorder (GAD)

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Cromwell, CT18–65 yrsAll genders
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A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Depressive Disorder, Major

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

New Haven, CT18–75 yrsAll genders
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Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation

Mental Health · Parenting / Maternal Behavior · Parenting Anxiety

This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.

Stamford, CT18+ yrsAll genders
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Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

Major Depression Disorder · Depression

The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

West Haven, CT21–65 yrsAll genders
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Aerobic Exercise and Obsessive-Compulsive Disorder Symptoms

Obsessive-Compulsive Disorder (OCD)

The purpose of this study is to examine the acute effects of exercise on cognitive flexibility and symptom reactivity. The main questions it aims to answer are: Does moderate intensity physical activity reduce subjective distress, compulsive urges, and intrusions- and increase cognitive flexibility- in adults with obsessive-compulsive disorder compared to low-intensity physical activity? Researchers will compare low- to moderate-intensity exercise to see if moderate physical activity increases cognitive flexibility and reduces symptom reactivity in adults with obsessive-compulsive disorder (OCD). Participants will: Complete self-report surveys, psychiatric interviews, and cognitive tasks. Be assigned to either a low- or moderate-intensity exercise condition and complete physical activity. Repeat cognitive and symptom measures following the exercise intervention.

New Haven, CT18–64 yrsAll genders
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Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life

Wellness · Quality of Life · Anxiety

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

New Haven, CT18–65 yrsAll genders
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E-Mindfulness Approaches for Living After Breast Cancer

Breast Cancer · Depression

NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Stamford, CT18–50 yrsAll genders
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Transcranial Direct Current Stimulation and Extinction in Obsessive Compulsive Disorder

Obsessive Compulsive Disorder (OCD)

Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Extinction learning is thought to be a core mechanism of therapeutic exposure. Fear and safety signal learning are traditionally associated with activity and connectivity within the canonical corticolimbic "fear circuit", which includes the amygdala, medial prefrontal cortex (mPFC), and hippocampus. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits and if transcranial direct current stimulation (tDCS) normalizes functional connectivity and safety signal processing to recover extinction deficits in obsessive-compulsive disorder (OCD).

New Haven, CT18–70 yrsAll genders
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Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Major Depressive Disorder

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Farmington, CT18–65 yrsAll genders
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Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs

Caregiver Anxiety · Caregiver Anxiety Related to Cancer Imaging · Pediatric Oncology

"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. The main purposes of this study are two-fold: 1). to determine if scanxiety exists in the caregivers of pediatric oncology patients and 2.) if scanxiety is found, does the implementation of a mindfulness program help to improve caregiver anxiety related to imaging.

Hartford, CT18+ yrsAll genders
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Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

Obsessive-Compulsive Disorder

The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.

New Haven, CT18–65 yrsAll genders
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Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Depressive Disorder, Major

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Farmington, CT18–74 yrsAll genders
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The OBSERVE Protocol

Major Depression Disorder

This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.

Milford, New Haven, CTAll agesAll genders
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Open-Label Psilocybin Study in Transdiagnostic Population

Transdiagnostic · Depression - Major Depressive Disorder · Anxiety

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

New Haven, CT18+ yrsAll genders
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Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Schizophrenia Spectrum and Other Psychotic Disorders · Schizophrenia · Delusional Disorder

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.

Hartford, CT18–40 yrsAll genders
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