Not Yet RecruitingNot Applicable

Multimodal Cohort Study of Generalized Anxiety Disorder

China400 participantsStarted 2026-08-01

Plain-language summary

Generalized anxiety disorder (GAD) is a common mental health condition characterized by persistent and excessive worry that is difficult to control. It can affect sleep, daily functioning, work, and quality of life. Some individuals experience long-lasting or recurrent symptoms, but the factors that influence the course and outcome of GAD are still not fully understood. The main purpose of this study is to establish a long-term cohort of people with GAD and to better understand how their symptoms and health change over time. The study will also explore factors that may help predict symptom improvement, recurrence, and treatment outcomes. Approximately 400 adults with GAD who receive care at Shanghai Mental Health Center will participate in this study. Participants will undergo regular clinical assessments and follow-up visits. During the study, researchers will collect information about participants' symptoms, medical and treatment history, blood samples, and brain-related measurements. Participants will be followed at several time points to observe changes in symptoms and health. The information collected will be used to better understand the course of GAD and to support the development of more individualized approaches to diagnosis, treatment, and long-term care.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Meets the ICD-10 diagnostic criteria for generalized anxiety disorder (GAD). Aged 18 to 65 years. Hamilton Anxiety Rating Scale (HAMA) total score \>14. Has at least a junior high school education and is able to complete self-report questionnaires. Voluntarily agrees to participate in the study and provides written informed consent. Exclusion Criteria: Meets ICD-10 diagnostic criteria for any psychiatric disorder other than GAD, as assessed using the Mini International Neuropsychiatric Interview (M.I.N.I.). Has significant suicidal ideation or is considered to be at high risk of suicide. Has a clinically significant medical condition or clinically significant laboratory abnormalities.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline

Timeframe: Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up

Trial details

NCT IDNCT07764211

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06-01

Contact for this trial

Lanying LIU

13516816012 balindaliu@126.com

View on ClinicalTrials.gov More Generalized Anxiety Disorder (GAD) trials