Investigation of Pathogenic Gut Microbiota Patterns in Anxiety, Depression and Panic Disorders

University of Toronto

Status: Not yet enrolling

Conditions: Panic Disorder; Depression; Mood Disorders; Anxiety

Treatments: Diagnostic Test: H pylori stool test; Diagnostic Test: Bacterial stool analysis

Study type: Observational

Funder types: Other

Identifiers

NCT07268729

Pro00084759

Details and patient eligibility

About

This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes and effective treatments, potentially offering a novel approach to achieving complete recovery.

Full description

Background: Anxiety, depression and panic disorders are among the most prevalent mental health conditions globally, affecting millions and imposing a substantial burden on individuals, families, and healthcare systems. These disorders often manifest through recurrent, severe episodes of anxiety and fear, frequently accompanied by physical symptoms such as palpitations, chest pain, and dizziness, which can lead to significant functional impairment and diminished quality of life. While current treatment options include pharmacotherapy and cognitive-behavioral therapy, response rates vary, and many patients experience residual symptoms or adverse effects, leading to high rates of treatment discontinuation. Furthermore, the growing recognition of treatment-resistant anxiety, depression and panic disorders highlights an urgent need for innovative, evidence-based therapies that provide sustained relief without compromising safety.

Introduction Anxiety, depression and panic disorders are pervasive and debilitating chronic mental health conditions, affecting approximately 20% of the global population over a lifetime. Characterized by episodes of intense fear and physical symptoms such as heart palpitations, shortness of breath, and dizziness, these disorders can severely impact daily functioning, interpersonal relationships, and overall quality of life. Individuals with these conditions are also at increased risk for comorbidities including depression, substance use disorders, and cardiovascular disease, further complicating their clinical profile and necessitating more comprehensive treatment strategies.

Despite the availability of pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, alongside cognitive-behavioral therapy (CBT), there remain substantial challenges in achieving and maintaining symptom relief. Response rates vary widely, and a significant proportion of patients experience partial or inadequate relief, with some exhibiting treatment-resistant symptoms. Moreover, pharmacological treatments can be associated with side effects like weight gain, fatigue, and cognitive impairment, which may lead to discontinuation or non-adherence. These limitations highlight a critical need for alternative or adjunctive interventions that can provide more effective, sustainable, and safer outcomes.

This trial was therefore designed to assess the prevalence of pathogenic gut bacteria among patients with anxiety, depression, and panic disorder compared to healthy controls.

Objective: This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes, potentially offering a novel approach to these conditions..

Findings from this study are anticipated to advance clinical understanding and treatment options for anxiety, depression and panic disorders, providing a potentially more effective approach and that provide lasting relief for patients struggling with these conditions.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Adults aged 18-65 years.

  • Either of the following:

    1. Diagnosed with anxiety, depression, or panic disorder according to DSM-5 criteria, regardless of current treatment status.
    2. Healthy individuals with no history of psychiatric disorders (control group).

  • Able to provide informed consent and stool sample.

Exclusion criteria

• • Diagnosis of psychotic disorders or neurocognitive conditions.

  • Use of systemic antibiotics or antifungals within the past 60 days.

Trial design

500 participants in 3 patient groups

Patients under ongoing treatment

Description:

Participants in this group are adults currently receiving ongoing treatment for anxiety, depression, or panic disorder. Treatment may include prescribed medication, psychotherapy, or other clinician-supervised care. These participants will complete the same baseline psychological assessments and stool microbiome testing as the other cohorts. Their data will help evaluate how existing treatments may influence gut microbiome composition and mental-health outcomes over time.

Treatment:

Diagnostic Test: Bacterial stool analysis

Diagnostic Test: H pylori stool test

Healthy controls with no psychiatric history

Description:

Participants in this group are healthy adults with no self-reported or clinically diagnosed history of psychiatric or neurological disorders. They will complete the same baseline assessments and biological sample collection (including stool microbiome testing) as the clinical cohort, but will not receive any treatment or individualized intervention. Their data will serve as a comparison reference to help identify microbiome and biomarker patterns associated with anxiety and depression.

Treatment:

Diagnostic Test: Bacterial stool analysis

Diagnostic Test: H pylori stool test

Patients with clinically confirmed anxiety, depression, and panic disorder.

Description:

Participants in this cohort are adults with a current, clinically confirmed diagnosis of anxiety disorder, depressive disorder, or panic disorder. Each participant will provide baseline psychological assessments and biological samples, including stool microbiome testing. Based on their results, they may receive individualized lifestyle or dietary recommendations under physician supervision. Participants will be followed over time to evaluate changes in mood, stress, and biological markers related to mental-health outcomes.

Treatment:

Diagnostic Test: Bacterial stool analysis

Diagnostic Test: H pylori stool test