Anxiety DisorderNCT03894085
Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （fMRI） Study With Paroxetine Treatment
A study testing Paroxetine in people with Anxiety Disorder and Obsessive-Compulsive Disorder, run by Central South University at 1 site in China.
Trial summary
To explore reliable neuroimaging biomarkers for anxiety disorder and OCD,and whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD, the investigators included30 drug-naive general anxiety disorder (GAD),30 drug-naïve panic disorder(PD),30 drug-naïve social anxiety… Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Obsessive-Compulsive Disorder
- What is being tested?
- Paroxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnostic criteria for GAD、PD、SAD、OCD patients according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
- Never received any treatment before,and with no psychotic symptoms
- For Healthy controls:Their first-degree relatives had no history of psychiatric disorders
Who cannot join
- Exclusion criteria for all participants were any other psychiatric diagnoses according to DSM-V; any physical illness such as liver and kidney diseases, cardiovascular diseases; any combined with other antipsychotic medications (both low and high doses), including typical and atypical antipsychotic,mood stabilizer, antidepressant drugs ; history of drug or alcohol abuse or dependence; obvious suicide attempts or behaviors; pregnancy or lactation. and any contraindications to MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （ fMRI ）Study With Paroxetine Treatment
To explore reliable neuroimaging biomarkers for anxiety disorder and OCD,and whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD, the investigators included30 drug-naive general anxiety disorder (GAD),30 drug-naïve panic disorder(PD),30 drug-naïve social anxiety disorder,30 drug-naive.obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment. The investigators will also evaluate the severity of symptom, social function, cognitive function and treatment response.
Read the detailed description
Previous studies suggest that there are brain anatomical and functional in patients with anxiety disorder and obsessive-compulsive disorder (OCD). However, it remains unclear whether these abnormalities can be used for the diagnosis of anxiety disorder、OCD and prediction of treatment effects. It is also unclear whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD.And it still lacks reliable neuroimaging biomarkers in anxiety disorder and OCD. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in 30 general anxiety disorder (GAD),30 panic disorder(PD),30 social anxiety disorder,30 obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment.First, neuroimaging biomarkers are definitively selected in subjects at different subtypes of anxiety disorder and OCD population for the purpose of diagnosis by using a cross-section design. After that, a longitudinal study is conducted in patients with anxiety disorder and OCD with 4 weeks of paroxetine treatment to validate that the selected neuroimaging biomarkers can be used to predict treatment response of medication. The definitively selected neuroimaging biomarkers are expected to be useful for the diagnosis of anxiety disorder and OCD, and prediction of treatment effects; and finally be helpful for understanding the pathophysiology of anxiety disorder and OCD.
- Conditions
- Anxiety Disorder, Obsessive-Compulsive Disorder
- Being tested
- Paroxetine
- Keywords
- anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
Paroxetine treatment for 4 weeks usage:20-80mg Qd
| Study group | Role | What they receive |
|---|---|---|
| GAD group | Experimental | 1. General anxiety disorder(GAD) patients meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks
3. Paroxetine (20-40mg) treatment for 4 weeks Receives: Drug: Paroxetine |
| PD group | Experimental | 1. Panic disorder(PD) patients meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks
3. Paroxetine (20-40mg)treatment for 4 weeks Receives: Drug: Paroxetine |
| SAD group | Experimental | 1. Social anxiety disorder(SAD)meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks
3. Paroxetine (20-40mg)treatment for 4 weeks Receives: Drug: Paroxetine |
| OCD group | Experimental | 1. Obsessive-compulsive disorder (OCD)meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks
3. Paroxetine(40-80mg) treatment for 4 weeks Receives: Drug: Paroxetine |
| Healthy controls | No intervention | MRI scan at baseline and no drugs treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
structural and function MRI data
A 3.0 T Siemens scanner was used to obtain the fMRI images in the Second Xiangya Hospital of Central South University.The MRI data wii be obtained before and after treatment at different follow up point.
Measured: 4 weeks
Hamilton anxiety scale(HAMA)
The change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point.
Measured: 4 weeks
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
The change of the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)total score, severity of obsessive-compulsive symptom before and after treatment at different follow up point.
Measured: 4 weeks
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
The investigators will use the Brief Cognitive Assessment Toolfor Schizophrenia (B-CATS) score as primary assess of cognitive function before and after treatment at different follow up point.
Measured: 4 weeks
Secondary outcomes (5)
Social Disability Screening Schedule(SDSS)
The investigators will use the Social Disability Screening(SDSS) score as assess of social function before and after treatment at different follow up point.
Measured: 4 weeks
Simplified Coping Style Questionnaire (SCSQ)
The investigators will use the Simplified Coping Style Questionnaire(SCSQ) scale score as assess of coping style at baseline and after 4 weeks
Measured: 4 weeks
Eysenck Personality Questionnaire(EPQ)
The investigators will use the Eysenck Personality Questionnaire (EPQ) scale as assess of characteristic of personality at baseline
Measured: at baseline
The 17-item Hamilton depression scale (HAMD-17)
The change of the 17-item Hamilton depression scale total score, severity of depressive symptom before and after treatment at different follow up point
Measured: 4 weeks
Liebowitz social anxiety scale(LSAS)
The change of the Liebowitz social anxiety scale (LSAS) total score,severity of social anxiety before and after treatment at different follow up point.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start30 May 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Wenbin, Central South University
- Investigators
- Wenbin Guo, MD Ph.D, Principal investigator, Central South UniversityXiaoxiao Shan, M.D, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894085
- Sponsor's protocol ID
- 2016YFC1307104
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Shared and distinctive neural substrates of generalized anxiety disorder with or without depressive symptoms and their roles in prognostic prediction. J Affect Disord. 2024 Mar 1;348:207-217. doi: 10.1016/j.jad.2023.12.067. Epub 2023 Dec 29.
PubMed 38160885Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Disrupted functional connectivity associated with cognitive impairment in generalized anxiety disorder (GAD) and comorbid GAD and depression: a follow-up fMRI study. J Psychiatry Neurosci. 2023 Nov 7;48(6):E439-E451. doi: 10.1503/jpn.230091. Print 2023 Nov-Dec.
PubMed 37935477
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （ fMRI ）Study With Paroxetine Treatment
- ClinicalTrials.gov ID
- NCT03894085
- Acronym / sponsor ID
- 2016YFC1307104
- Conditions
- Anxiety Disorder, Obsessive-Compulsive Disorder
- Keywords
- anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Mar 2019 (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.
To explore reliable neuroimaging biomarkers for anxiety disorder and OCD,and whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD, the investigators included30 drug-naive general anxiety disorder (GAD),30 drug-naïve panic disorder(PD),30 drug-naïve social anxiety disorder,30 drug-naive.obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment. The investigators will also evaluate the severity of symptom, social function, cognitive function and treatment response.
Detailed description
Previous studies suggest that there are brain anatomical and functional in patients with anxiety disorder and obsessive-compulsive disorder (OCD). However, it remains unclear whether these abnormalities can be used for the diagnosis of anxiety disorder、OCD and prediction of treatment effects. It is also unclear whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD.And it still lacks reliable neuroimaging biomarkers in anxiety disorder and OCD. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in 30 general anxiety disorder (GAD),30 panic disorder(PD),30 social anxiety disorder,30 obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment.First, neuroimaging biomarkers are definitively selected in subjects at different subtypes of anxiety disorder and OCD population for the purpose of diagnosis by using a cross-section design. After that, a longitudinal study is conducted in patients with anxiety disorder and OCD with 4 weeks of paroxetine treatment to validate that the selected neuroimaging biomarkers can be used to predict treatment response of medication. The definitively selected neuroimaging biomarkers are expected to be useful for the diagnosis of anxiety disorder and OCD, and prediction of treatment effects; and finally be helpful for understanding the pathophysiology of anxiety disorder and OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GAD group | Experimental | Drug: Paroxetine1. General anxiety disorder(GAD) patients meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg) treatment for 4 weeks |
| PD group | Experimental | Drug: Paroxetine1. Panic disorder(PD) patients meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg)treatment for 4 weeks |
| SAD group | Experimental | Drug: Paroxetine1. Social anxiety disorder(SAD)meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg)treatment for 4 weeks |
| OCD group | Experimental | Drug: Paroxetine1. Obsessive-compulsive disorder (OCD)meet the diagnostic criteria of the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine(40-80mg) treatment for 4 weeks |
| Healthy controls | No intervention | –MRI scan at baseline and no drugs treatment |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnostic criteria for GAD、PD、SAD、OCD patients according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V)
- Never received any treatment before,and with no psychotic symptoms
- For Healthy controls:Their first-degree relatives had no history of psychiatric disorders
Key exclusion criteria (1 listed)
- Exclusion criteria for all participants were any other psychiatric diagnoses according to DSM-V; any physical illness such as liver and kidney diseases, cardiovascular diseases; any combined with other antipsychotic medications (both low and high doses), including typical and atypical antipsychotic,mood stabilizer, antidepressant drugs ; history of drug or alcohol abuse or dependence; obvious suicide attempts or behaviors; pregnancy or lactation. and any contraindications to MRI scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParoxetineParoxetine treatment for 4 weeks usage:20-80mg Qd | Drug | GAD group, OCD group, PD group, SAD group |
Primary outcome
structural and function MRI data
Time frame: 4 weeks
A 3.0 T Siemens scanner was used to obtain the fMRI images in the Second Xiangya Hospital of Central South University.The MRI data wii be obtained before and after treatment at different follow up point.
Hamilton anxiety scale(HAMA)
Time frame: 4 weeks
The change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point.
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Time frame: 4 weeks
The change of the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)total score, severity of obsessive-compulsive symptom before and after treatment at different follow up point.
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time frame: 4 weeks
The investigators will use the Brief Cognitive Assessment Toolfor Schizophrenia (B-CATS) score as primary assess of cognitive function before and after treatment at different follow up point.
5 secondary outcomes
Social Disability Screening Schedule(SDSS)
Time frame: 4 weeks
Simplified Coping Style Questionnaire (SCSQ)
Time frame: 4 weeks
Eysenck Personality Questionnaire(EPQ)
Time frame: at baseline
The 17-item Hamilton depression scale (HAMD-17)
Time frame: 4 weeks
Liebowitz social anxiety scale(LSAS)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 38160885Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Shared and distinctive neural substrates of generalized anxiety disorder with or without depressive symptoms and their roles in prognostic prediction. J Affect Disord. 2024 Mar 1;348:207-217. doi: 10.1016/j.jad.2023.12.067. Epub 2023 Dec 29.
- Derived from this study: PubMed 37935477Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Disrupted functional connectivity associated with cognitive impairment in generalized anxiety disorder (GAD) and comorbid GAD and depression: a follow-up fMRI study. J Psychiatry Neurosci. 2023 Nov 7;48(6):E439-E451. doi: 10.1503/jpn.230091. Print 2023 Nov-Dec.
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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. This study is not recruiting at the moment.
Wenbin Guo, MD Ph.D principal investigator
Central South University
Xiaoxiao Shan, M.D principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paroxetine in people with Anxiety Disorder and Obsessive-Compulsive Disorder, run by Central South University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
structural and function MRI data (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894085, which also lists 2 linked publications.
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 21 Aug 2024.