Clinical trial NCT03199625: Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Official title: Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Panic Disorder
Keywords: cognitive-behavior therapy
magnetic resonance imaging
Panic Disorder
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research
timeFrame: an expected average of 6 months
measure: Magnetic Resonance Imaging
timeFrame: Time Frame: an expected average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Chun Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: