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
NCT06846320 · Generalized Anxiety Disorder (GAD)
RecruitingGeneralized 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.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereHuntsville, Alabama, United States + 51 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
NCT05215353 · Survivorship
RecruitingThe researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.
PhasePhase 4
TypeInterventional
Age18 Years
WhereMiami, Florida, United States + 2 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
NCT07221578 · Social Anxiety Disorder (SAD)
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WherePhoenix, Arizona, United States + 28 more
SponsorVanda Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Minority Health Through Biofeedback and Stress Reduction
NCT07172152 · Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety
RecruitingThis study aims to evaluate the effectiveness of a four-week heart rate variability (HRV) biofeedback intervention to improve physiological stress response, emotion regulation, and anxiety-related symptoms in young ethnic minority adults with a family history of cardiovascular disease (CVD). Participants will be randomly assigned to either an intervention group, where they will engage in guided paced breathing exercises, or a control group, which will follow standard conditions without the intervention. The study consists of five sessions, including an initial assessment, three weekly check-in sessions, and a final post-intervention assessment. Participants will practice paced breathing at home and attend brief in-lab sessions to track progress. Physiological and psychological measures, such as HRV, GSR, BP, anxiety levels, and responses to the Socially Evaluated Cold Pressor Test (SECPT), will be used to assess outcomes. Findings from this study may provide insights into accessible, non-invasive stress management interventions to mitigate CVD risk in high-risk populations.
PhaseNA
TypeInterventional
Age18 Years – 35 Years
WhereMiami, Florida, United States
SponsorAmelia Saul, PhD, CTRS, BCB
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cultural Adaptation of a SSI for Youth Anxiety
NCT04729504 · Anxiety Disorders
RecruitingThe overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.
PhaseNA
TypeInterventional
Age18 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study
NCT06595251 · Overweight, Obesity, Hypertension
RecruitingThe Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.
Phase—
TypeObservational
Age6 Years – 14 Years
WhereMiami, Florida, United States
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT06701903 · Generalized Anxiety Disorder
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 59 more
SponsorIntra-Cellular Therapies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
NCT06596265 · Anxiety, Wellness, Psychological, Overweight or Obesity
RecruitingThe Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.
Phase—
TypeObservational
Age12 Years – 17 Years
WhereMiami, Florida, United States
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Radiotherapy Patient Education With Virtual Reality
NCT06506435 · Anxiety, Cancer
RecruitingThe purpose of this research study is to investigate the impact of virtual reality experiences on individuals undergoing radiotherapy, aiming to assess whether this immersive technology can reduce anxiety and enhance patient overall treatment satisfaction. By comparing different virtual reality techniques and a standard informational video, the study seeks to identify optimal strategies for leveraging virtual reality to improve the patient experience during radiotherapy.
PhaseNA
TypeInterventional
Age18 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT06480383 · Generalized Anxiety Disorder
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.
PhasePhase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 68 more
SponsorIntra-Cellular Therapies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial on Agitation in Alzheimer's Dementia
NCT05543681 · Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden
RecruitingThe purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.
PhasePhase 2
TypeInterventional
Age60 Years
WhereMaitland, Florida, United States + 29 more
SponsorIGC Pharma, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mental Health in Primary Care
NCT05426057 · Depression, Anxiety, Suicide, Drug Use
RecruitingThe goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.
PhaseNA
TypeInterventional
Age12 Years – 16 Years
WhereMiami, Florida, United States + 16 more
SponsorUniversity of Miami
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