Clinical Research Directory

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 JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment

The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).

A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.

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.

CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder

This open-label, single-group, non-randomized interventional study will evaluate longitudinal changes in anxiety symptoms, sleep quality, psychological well-being, treatment adherence, tolerability, and safety in adults with clinician-confirmed generalized anxiety disorder. Participants will receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at a protocol dose of 0.5 mL approximately every 12 hours for 8 weeks. Follow-up will continue through Week 12. The study has no placebo or concurrent comparator group. The primary outcome is change in the Generalized Anxiety Disorder 7-item scale (GAD-7) total score from baseline to Week 8. Findings will be descriptive and hypothesis-generating; the design cannot establish that any observed change was caused by the product.

Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms

This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) as an adjunctive treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants in the clinical trial will receive monotherapy with one of three SSRIs: sertraline, paroxetine, or escitalopram, selected by a psychiatrist according to clinical suitability, previous treatment response, and tolerability. Clinical efficacy will be assessed using the Hamilton Anxiety Rating Scale (HAMA). The neuroimaging substudy will include healthy controls and two groups of patients with GAD receiving SSRI monotherapy with an unchanged medication type and daily dose for at least 2 weeks: an EA group and a sham EA group. Healthy controls will undergo a single resting-state functional MRI (rs-fMRI) scan, whereas patients will undergo scans before and after a single 30-minute EA or sham EA session on the same day. Functional connectivity (FC), regional homogeneity (ReHo), and amplitude of low-frequency fluctuation (ALFF) will be compared between healthy controls and patients before intervention, and pre-to-post changes will be compared between the EA and sham EA groups.

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.

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.

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

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation

Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and obsessive-compulsive disorder, which is why researchers describe it as a transdiagnostic feature. A type of therapy called Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has been shown to reduce anxiety in previous trials. What remains to be known is how uncertainty changes when targeted directly, and whether the same mechanism applies across diagnoses. IU has mostly been measured using questionnaires, which indicate whether people find uncertainty difficult, but not what is actually happening when they encounter it. Recent research suggests that IU is not a single trait but a set of differences in how people estimate different kinds of uncertainty. Therefore, in addition to standard questionnaires, computer-based tasks will be used to explore an "uncertainty fingerprint" for each participant, capturing different aspects of uncertainty processing in a way that self-report measures cannot. In this study, the investigators are comparing CBT-IU, adapted to work across disorders, against Applied Relaxation. Applied relaxation is a well-established therapy that teaches people to notice and release physical tension but does not focus on uncertainty. Adults with high IU and anxiety symptoms (regardless of formal diagnosis) will be randomly allocated to one of the two 12-session group therapies. The investigators will measure anxiety and IU using standard questionnaires as the primary outcomes. Additionally, cognitive tasks will be used to measure the uncertainty fingerprint before therapy, immediately after, and three months later. The aim is to test whether reductions in IU are specific to CBT-IU rather than shared with an equally credible therapy that does not target uncertainty. Going beyond self-reports, the trial will then begin to resolve which specific aspects of uncertainty processing change, so that future treatments can be more precisely targeted and better matched to each person.

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.

Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which emotional regulation processes and common factor of the intervention itself are involved in the therapeutic improvement. The investigators will compare the interventions of four groups: ultra-brief group treatment (1), brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group. The main questions the study aims to answer are: * Will the brief and ultra-brief treatment formats works better than the relaxation-based control group? * Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar? * Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance? * Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.

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

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

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

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder

The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)

LIFU for Chronic Pain and Generalized Anxiety Disorder

A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.

Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Participants will be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC). Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. The primary objective is to compare changes in anxiety symptom severity, measured using the Hamilton Anxiety Rating Scale (HAM-A), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, quality of life, sleep quality, cognitive function, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).

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

Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder

Anxiety and obsessive-compulsive disorders are among the most common in children. Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one method to increase access to care. The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.

Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)

Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.

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.

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.

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.