Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research

Panic Disorder Clinical Trial

Official title:

Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199625
• Other study ID #: 81571344
• Status: Recruiting
• Phase: Phase 2
• First received: June 20, 2017
• Last updated: June 23, 2017
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Nanjing Medical University
• Contact: Chun Wang, doctor
• Phone: 86 15850566376
• Email: fm51109[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive behavioral therapy (CBT), which includes cognitive therapy (CT) and behavioral therapy (BT), is the first-line treatment for patients with panic disorder (PD). However, the neural mechanism of CBT is unknown. The exploration of mechanism is of great significance for clinical strategy formulation. This study is proposed on the basis of our early PD and CBT neuroimaging studies, adopt the design of prospective randomized controlled intervention study, set up three time points: before the treatment（week 0）, the initial treatment (week 4th), the plateau treatment (week 28th). With normal subjects as black control and antidepressant therapy as intervention comparison, this study set up CT and BT two intervention groups, respectively collect all the participants'symptomatological, psychological, cognitive function and brain imaging data (3D,DTI, fMRI in resting and tasks states) at week 0, week 4th and week 28th. This study is based on the advanced analysis methods we applied in the early study,including BOLD-fMRI, DTI, topological characteristics analysis of the whole brain network and Granger causality test etc. It is from the point of multiple levels(brain regions, circuits, whole brain), multimodal (structure, function) to comprehensively analysis the role of CT and BT for the function and structure of brain regions, circuits (mood regulating circuit and cognitive control network for emotion processing) and whole brain in patients with PD. Totally, we explore the target area, path and mechanism of CBT for emotion processing neural circuits in patients with PD, and combined with the clinical data we preliminarily explore the imaging biomarkers of different intervention methods which may predict therapeutic effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• meet DSM-5 and Mini-international neuropsychiatric interview (MINI) Chinese version panic disorder diagnosis;

• the age of 20-50 years old;

• Right handedness;

• patients to participate voluntarily, with the consent of their families, signed informed consent book.

Exclusion Criteria:

• neurological diseases or other mental illnesses;

• serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);

• treatment by psychotropic medications,psychological treatment, electroconvulsive therapy or physical therapy within 3 months prior to the start of the trial;

• with contraindication for MRI

• pregnancy and lactation.

Related Conditions & MeSH terms

• Disease
• Panic Disorder

Intervention

Behavioral:
• Cognitive therapy

• Behavior therapy

Drug:
• SSRI antidepressants

Locations

Country	Name	City	State
China	Nanjing Brain Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research	The 14-item version of the Hamilton Rating Scale for Anxiety (HAMA; Hamilton, 1959) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 56. Lower scores show more mild anxiety.	an expected average of 6 months
Primary	Magnetic Resonance Imaging		Time Frame: an expected average of 6 months