Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01460212
• Other study ID #: QYK09184
• Status: Recruiting
• Phase: Phase 4
• First received: October 24, 2011
• Last updated: September 24, 2014
• Start date: December 2011
• Est. completion date: October 2015

Study information

• Verified date: September 2014
• Source: Nanjing Medical University
• Contact: Chun Wang, doctor
• Phone: 86 15850566376
• Email: fm51109[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.

Description:

Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• meet SCID -?/P major depressive disorder diagnosis;

• Right handedness;

• good visual acuity.

Exclusion Criteria:

• neurological disease ;

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

• with other mental disorder;

• psychotic symptoms

• personality disorders;

• pregnancy;

• suicidal risk;

• treatment by antidepressants or other psychotropic medications within 6 months prior to the start of the trial;

• with contraindication for MRI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SSRI antidepressants
SSRI antidepressants are Selective serotonin reuptake inhibitors. They include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.

Behavioral:
• Cognitive-Behavior Therapy
The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory

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 Rating Scale for Depression (HAMD)	The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.	an expected average of 6 months	Yes
Secondary	Magnetic Resonance Imaging		an expected average of 6 months	Yes