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 Teen Recovery Through Inspiration, Support, and Empowerment
NCT07170657 · Suicidal Ideation, Suicide Attempt, Anxiety
RecruitingThe goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources. The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with online access to an RES, TP, and PSS. * Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4. * Week 5 and 7: one-one meetings with PSS and TP for education and support. * Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8. Cohort B will be the SOC group with no PSS, TP, or RES. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
PhaseNA
TypeInterventional
Age15 Years – 18 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
NCT06615557 · Social Anxiety Disorder (SAD)
RecruitingThis U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-4 and choose to enter the distinct open-label extension phase of the study.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WherePhoenix, Arizona, United States + 25 more
SponsorVistaGen Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Measurement-Based Peer Supervision App for Non-Specialist Providers
NCT07082010 · Training of Mental Health Professionals, Training of Frontline Health Workers
RecruitingThe goal of this project is to enhance and evaluate the efficacy of a scalable digital solution designed to help train and support the work of non-specialist providers (NSPs), such as community health workers, to deliver therapy to individuals with anxiety and/or depression. The main questions this project aims to answer are: * Can a digital tool help NSPs feel more confident in counseling patients? * How can a digital tool be designed to optimally support the work of NSPs?
PhaseNA
TypeInterventional
Age18 Years
WhereDallas, Texas, United States
SponsorDimagi Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Targeting Social Function in Anxiety and Eating Disorders
NCT06198023 · Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
RecruitingSocial processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task. Participants will: * attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks * complete a pre-intervention assessment with questionnaires * attend eight sessions of their assigned treatment group over the course of 12 weeks * complete three virtual follow-up assessments 4, 8, and 12 months from their baseline * attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks Researchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if * patients can be treated effectively with education alone or if an interactive group component produces additional benefits * cognitive and behavioral task performance are associated with recovery or illness state.
PhaseNA
TypeInterventional
Age18 Years – 30 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Recovery Through Inspiration, Support, and Empowerment
NCT07051200 · Suicidal Ideation, Suicide Attempt, Anxiety
RecruitingThe goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources. The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with PSS and RCOs. * Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks. Cohort B will be the SOC group with no PSS or RCOs. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
PhaseNA
TypeInterventional
Age18 Years – 27 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾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 Resilience in Adolescent Development
NCT03458936 · Risk Assessment, Resilience, Psychological, Depression
RecruitingRAD is a 10-year natural history, longitudinal, prospective assessment study of a cohort of 2,500 participants (ages 10-24 years) that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to resilience among children, adolescents, and young adults at-risk for mood and anxiety disorders. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters, including socio-demographic, life habits, clinical, biological, behavioral, neurophysiological, and neuroimaging. The study is designed to observe and collect factors associated with resilience in a non-invasive fashion; no interventions or treatments will be conducted during the project. Assessments will be conducted up to 4 times per year for up to 10 years, as well as a baseline visit. Study visits will be conducted in person whenever feasible but may be completed by phone/mail/computer, if an in-person visit is not possible.
Phase—
TypeObservational
Age10 Years – 24 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾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 A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
NCT06741228 · Generalized Anxiety Disorder
RecruitingA Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WhereGilbert, Arizona, United States + 35 more
SponsorDefinium Therapeutics US, Inc.
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