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

NCT03894085 | Completed

• 1 other identifier: 2016YFC1307104
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Obsessive-Compulsive Disorder

Keywords

anxiety disorder; obsessive-compulsive disorder; neuroimaging; biomarkers; treatment response

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  4 weeks

Secondary Outcomes (5)

• Social Disability Screening Schedule(SDSS)

  4 weeks

• Simplified Coping Style Questionnaire (SCSQ)

  4 weeks

• Eysenck Personality Questionnaire(EPQ)

  at baseline

• The 17-item Hamilton depression scale (HAMD-17)

  4 weeks

• Liebowitz social anxiety scale(LSAS)

  4 weeks

Study Arms (5)

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

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

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

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

Drug: Paroxetine

Healthy controls

NO INTERVENTION

MRI scan at baseline and no drugs treatment

Interventions

Paroxetine DRUG

Paroxetine treatment for 4 weeks usage:20-80mg Qd

GAD group; OCD group; PD group; SAD group

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Related Publications (2)

• 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.

  PMID: 38160885 DERIVED

• Han 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.

  PMID: 37935477 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wenbin Guo, MD Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

• Xiaoxiao Shan, M.D

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 28, 2019
• Study Start: May 30, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)