Generalized Anxiety Disorder (GAD)MC-GADNCT07764211
Multimodal Cohort Study of Generalized Anxiety Disorder
An observational study of Generalized Anxiety Disorder (GAD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients with generalized anxiety disorder (GAD) receiving outpatient or inpatient care at Shanghai Mental Health Center, including both first-episode and non-first-episode GAD. Potential participants will be identified through clinical screening and assessed for eligibility by trained research personnel. Approximately 400 participants will be enrolled and followed prospectively.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai
Lanying LIU, balindaliu@126.com
About this study
Official title: A Cohort Study of Generalized Anxiety Disorder Based on Multimodal Data
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.
Read more
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.
Read the detailed description
Generalized anxiety disorder (GAD) is a heterogeneous psychiatric disorder with substantial variation in clinical presentation, treatment response, disease course, and risk of recurrence. Current diagnosis and clinical management are mainly based on clinical interviews and symptom assessments, while objective markers that can assist in diagnosis, assessment of disease severity, and prediction of long-term outcomes remain limited. This prospective cohort study is designed to characterize the longitudinal course of GAD and to integrate clinical and biological information collected over time.
Participants enrolled in the cohort will receive treatment according to routine clinical practice rather than being assigned to a specific intervention by the study protocol. Information on current treatments, including pharmacological, psychological, and physical treatments, will be recorded during follow-up. Changes in anxiety symptoms, associated symptoms, treatment response, adverse events, and other clinical characteristics will be assessed longitudinally. The study will examine patterns of symptom change and identify factors associated with persistence, recurrence, treatment response, and prognosis.
A multimodal data collection framework will be used to characterize GAD from complementary clinical and biological perspectives. In addition to demographic, clinical, medical, treatment, and family-history information, the study will collect blood samples and multiple types of brain-related data. These include electroencephalography, magnetic resonance imaging, magnetoencephalography, and functional near-infrared spectroscopy. Computerized neuropsychological assessments will be used to evaluate cognitive domains such as executive function, decision-making, reward processing, and emotion recognition. Dynamic information such as heart rate variability, sleep patterns, and changes in emotional state will also be collected.
Participants will undergo repeated follow-up assessments after baseline. Follow-up visits are scheduled at weeks 2, 4, 8, 12, 24, 36, and 48, followed by an additional one-year extended follow-up. At these visits, researchers will assess changes in symptoms and current treatment, record adverse events, and collect selected clinical, blood, electrophysiological, neuroimaging, neuropsychological, and real-time health data according to the study schedule.
By integrating longitudinal clinical information with multimodal biological data, this study aims to characterize the clinical course of GAD, explore potential objective biomarkers, identify factors associated with treatment response and prognosis, and develop models for individualized outcome prediction. The resulting longitudinal database is expected to provide a foundation for risk stratification and more individualized approaches to the diagnosis, treatment, and long-term management of GAD.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GAD Cohort | Participants diagnosed with generalized anxiety disorder (GAD) who receive routine clinical care. No specific treatment or intervention is assigned by the study protocol. Participants will be followed longitudinally, and information on clinical symptoms, treatments, blood samples, and multimodal neurophysiological and neuroimaging measures will be collected according to the study schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline
The Hamilton Anxiety Rating Scale (HAMA) is a clinician-rated scale used to assess the severity of anxiety symptoms. The scale consists of 14 items, each rated from 0 to 4, resulting in a total score ranging from 0 to 56. Higher scores indicate greater severity of anxiety symptoms. Changes in HAMA total scores from baseline will be assessed during follow-up.
Measured: Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764211
- Sponsor's protocol ID
- 2026-47
- Other IDs
- 2025-CBDL02
- Acronym
- MC-GAD
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Generalized Anxiety Disorder Based on Multimodal Data
- ClinicalTrials.gov ID
- NCT07764211
- Acronym / sponsor ID
- MC-GAD / 2026-47
- Conditions
- Generalized Anxiety Disorder (GAD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Generalized anxiety disorder (GAD) is a heterogeneous psychiatric disorder with substantial variation in clinical presentation, treatment response, disease course, and risk of recurrence. Current diagnosis and clinical management are mainly based on clinical interviews and symptom assessments, while objective markers that can assist in diagnosis, assessment of disease severity, and prediction of long-term outcomes remain limited. This prospective cohort study is designed to characterize the longitudinal course of GAD and to integrate clinical and biological information collected over time.
Participants enrolled in the cohort will receive treatment according to routine clinical practice rather than being assigned to a specific intervention by the study protocol. Information on current treatments, including pharmacological, psychological, and physical treatments, will be recorded during follow-up. Changes in anxiety symptoms, associated symptoms, treatment response, adverse events, and other clinical characteristics will be assessed longitudinally. The study will examine patterns of symptom change and identify factors associated with persistence, recurrence, treatment response, and prognosis.
A multimodal data collection framework will be used to characterize GAD from complementary clinical and biological perspectives. In addition to demographic, clinical, medical, treatment, and family-history information, the study will collect blood samples and multiple types of brain-related data. These include electroencephalography, magnetic resonance imaging, magnetoencephalography, and functional near-infrared spectroscopy. Computerized neuropsychological assessments will be used to evaluate cognitive domains such as executive function, decision-making, reward processing, and emotion recognition. Dynamic information such as heart rate variability, sleep patterns, and changes in emotional state will also be collected.
Participants will undergo repeated follow-up assessments after baseline. Follow-up visits are scheduled at weeks 2, 4, 8, 12, 24, 36, and 48, followed by an additional one-year extended follow-up. At these visits, researchers will assess changes in symptoms and current treatment, record adverse events, and collect selected clinical, blood, electrophysiological, neuroimaging, neuropsychological, and real-time health data according to the study schedule.
By integrating longitudinal clinical information with multimodal biological data, this study aims to characterize the clinical course of GAD, explore potential objective biomarkers, identify factors associated with treatment response and prognosis, and develop models for individualized outcome prediction. The resulting longitudinal database is expected to provide a foundation for risk stratification and more individualized approaches to the diagnosis, treatment, and long-term management of GAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAD Cohort | – | –Participants diagnosed with generalized anxiety disorder (GAD) who receive routine clinical care. No specific treatment or intervention is assigned by the study protocol. Participants will be followed longitudinally, and information on clinical symptoms, treatments, blood samples, and multimodal neurophysiological and neuroimaging measures will be collected according to the study schedule. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients with generalized anxiety disorder (GAD) receiving outpatient or inpatient care at Shanghai Mental Health Center, including both first-episode and non-first-episode GAD. Potential participants will be identified through clinical screening and assessed for eligibility by trained research personnel. Approximately 400 participants will be enrolled and followed prospectively.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline
Time frame: Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up
The Hamilton Anxiety Rating Scale (HAMA) is a clinician-rated scale used to assess the severity of anxiety symptoms. The scale consists of 14 items, each rated from 0 to 4, resulting in a total score ranging from 0 to 56. Higher scores indicate greater severity of anxiety symptoms. Changes in HAMA total scores from baseline will be assessed during follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Anxiety Disorder (GAD), run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lanying LIU (13516816012, balindaliu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline (time frame: Baseline; Weeks 2, 4, 8, 12, 24, 36, and 48; and 1-year extended follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.