Clinical Research Directory

Massage for GAD: Neuroimaging and Clinical Correlates of Response

This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety. This is a randomized research study and subjects will be randomized into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups: 1. Swedish massage therapy twice per week for 6 weeks. 2. Light touch therapy twice per week for 6 weeks. The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder. Subjects will undergo two fMRI scanning sessions (one before and one after) twice per week for 6 weeks of touch intervention. Subjects will also be asked to complete questionnaires on anxiety, stress and depression.

A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Anxiety Skills Study

The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.

Metacognitive Therapy Compared to Cognitive-behavioral Therapy

This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

This 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.

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

This 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.

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)

The purpose of this proof-of-concept trial is to examine the safety, tolerability, and pharmacokinetics (PK), and preliminary clinical efficacy of CYB004 participants with GAD.

A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder

This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder

The goal of this clinical trial is to compare two psychological treatments for Generalized Anxiety Disorder. The main questions it aims to answer are: How well do these treatments work compared to earlier studies? Is one of the treatments more effective than the other? Are the treatments working the way that we think they do? Specifically, do changes in the variables that these treatments aim to target predict changes in anxiety symptoms? Participants will be randomized to two different internet-based cognitive behavioral therapy (ICBT) programs: Intolerance of uncertainty-based ICBT and metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. A psychologist will respond to the participants assignments and exercises and will respond to messages.

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

Qualitative Study of Student Financial Insecurity and Psychiatry

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of the study is to explore the lived experiences of the students concerned in order to identify what they perceive as the various aspects of student precarity (housing, transport, isolation, financial difficulties, etc.) and the links they perceive between these and their psychological distress. This study will deepen our understanding of these factors by exploring students' lived experiences, and will bring to light elements not identified by quantitative studies.

Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.

The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom. Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health. The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.

Group CBT for Intolerance of Uncertainty

Generalized anxiety disorder (GAD) is a debilitating condition involving excessive and uncontrollable worry and anxiety. Difficulty tolerating the uncertainties of life, known as intolerance of uncertainty (IU), has been shown to be key in the development and maintenance of GAD symptoms. A new, streamlined cognitive-behavioural treatment that targets IU has been shown to be effective in at reducing GAD symptoms, IU, and general psychopathology when delivered one-on-one with a therapist, as shown in a recently published pilot study. The individual format of this treatment is now being evaluated in a randomized controlled trial (RCT). The overall objective of this study is to pilot test a group version of the treatment protocol to determine if a future RCT of this group treatment is both warranted and feasible. We will also conduct a preliminary investigation into the group treatment's efficacy. A total of two pilot groups (N = 12-20) will be conducted with participants recruited from two clinical hospital sites in Winnipeg, Manitoba, Canada. The group treatment protocol will be delivered over the course of 12 weekly therapy sessions. Participants will complete assessment measures at pretreatment, posttreatment, and at a 3-month follow-up point. All assessments and treatment sessions will be conducted virtually via videoconferencing platform due to ongoing COVID-19 pandemic restrictions.

Mindful Self-Compassion for Anxiety Disorders and Depression

The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.

Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

MBSR Mechanisms in GAD

The purpose of this study is to understand the neural mechanisms that drive response to MBSR compared to stress education in patients with generalized anxiety disorder (GAD), and to examine the degree to which sex differences in MBSR response are explained by sex differences in these mechanisms. A total of 150 eligible participants with a primary diagnosis of GAD will be randomized to either an 8-week group MBSR or stress education program. The study will include preliminary screening, experimental visits, including fMRI, group intervention visits, and assessments at baseline, endpoint, and 3-month follow-up.

Use of CBD in the Treatment of Anxiety

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generalized Anxiety Disorder

This is a single dose study to investigate the efficacy, safety, tolerability and the PK, of SYT-510 in participants who meet diagnostic criteria of GAD. This study represents an evaluation of the effects of SYT-510 in participants meeting DSM-5 GAD diagnostic criteria. As a single dose study, it is designed to evaluate the efficacy of SYT-510 on neurobiological and behavioral markers associated with anxiety and will inform the design of future clinical trials in anxiety disorders. By integrating efficacy / PD, safety, tolerability, and PK measures within the same study framework, the study enables the translational value of the program, ensuring a more comprehensive understanding of SYT-510 effects in patients with generalized anxiety disorders. The plan is to evaluate a single dose of SYT-510 as compared with its matching placebo in a two-way crossover design, separated by a washout period of 7 to 14 days.

Student Precarity and Psychiatry

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services. Our study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.

CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"