- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199625
Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research
June 23, 2017 updated by: Chun Wang, Nanjing Medical University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chun Wang, doctor
- Phone Number: 86 15850566376
- Email: fm51109@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- Nanjing Brain Hospital
-
Principal Investigator:
- Chun Wang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Therapy group
treatment with Cognitive Therapy
|
Other Names:
|
Experimental: Behavior Therapy group
treatment with Behavior Therapy
|
Other Names:
|
Active Comparator: SSRI antidepressants
treatment by SSRI antidepressant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Anxiety Scale behavior therapy for patients with panic disorder: a dynamic research
Time Frame: an expected average of 6 months
|
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
|
Magnetic Resonance Imaging
Time Frame: Time Frame: an expected average of 6 months
|
Time Frame: an expected average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chun Wang, doctor, Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 23, 2017
First Posted (Actual)
June 27, 2017
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 23, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81571344
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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