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Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging (fMRI) Study With Paroxetine Treatment

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ClinicalTrials.gov Identifier: NCT03894085
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Guo Wenbin, Central South University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Obsessive-Compulsive Disorder Drug: Paroxetine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: GAD group
  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
Drug: Paroxetine
Paroxetine treatment for 4 weeks usage:20-80mg Qd

Experimental: PD group
  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
Drug: Paroxetine
Paroxetine treatment for 4 weeks usage:20-80mg Qd

Experimental: SAD group
  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
Drug: Paroxetine
Paroxetine treatment for 4 weeks usage:20-80mg Qd

Experimental: OCD group
  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
Drug: Paroxetine
Paroxetine treatment for 4 weeks usage:20-80mg Qd

No Intervention: Healthy controls
MRI scan at baseline and no drugs treatment



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Social Disability Screening Schedule(SDSS) [ Time Frame: 4 weeks ]
    The investigators will use the Social Disability Screening(SDSS) score as assess of social function before and after treatment at different follow up point.

  2. Simplified Coping Style Questionnaire (SCSQ) [ Time Frame: 4 weeks ]
    The investigators will use the Simplified Coping Style Questionnaire(SCSQ) scale score as assess of coping style at baseline and after 4 weeks

  3. Eysenck Personality Questionnaire(EPQ) [ Time Frame: at baseline ]
    The investigators will use the Eysenck Personality Questionnaire (EPQ) scale as assess of characteristic of personality at baseline

  4. The 17-item Hamilton depression scale (HAMD-17) [ Time Frame: 4 weeks ]
    The change of the 17-item Hamilton depression scale total score, severity of depressive symptom before and after treatment at different follow up point

  5. Liebowitz social anxiety scale(LSAS) [ Time Frame: 4 weeks ]
    The change of the Liebowitz social anxiety scale (LSAS) total score,severity of social anxiety before and after treatment at different follow up point.



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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894085


Contacts
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Contact: Wenbin Guo, M.D.Ph.D +8613875936768 guowenbin76@csu.edu.cn

Locations
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China
The Second Xiangya Hospital of Central South University Recruiting
Changsha, China
Contact: Wenbin Guo, professor       guowenbin76@csu.edu.cn   
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Wenbin Guo, MD Ph.D Central South University
Principal Investigator: Xiaoxiao Shan, M.D Central South University

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Responsible Party: Guo Wenbin, Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University, Central South University
ClinicalTrials.gov Identifier: NCT03894085     History of Changes
Other Study ID Numbers: 2016YFC1307104
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guo Wenbin, Central South University:
anxiety disorder
obsessive-compulsive disorder
neuroimaging
biomarkers
treatment response
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Personality Disorders
Disease
Anxiety Disorders
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors