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

Phase 4

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Cognitive-Behavior Therapy; Drug: SSRI antidepressants

• Registration Number: NCT01460212
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Study Start: 2011-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25
• Primary Completion: 2014-12
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• meet SCID -Ⅰ/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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavior Therapy group	Cognitive-Behavior Therapy	treatment with Cognitive-Behavior Therapy
SSRI antidepressants	SSRI antidepressants	treatment by SSRI antidepressant

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAMD)	an expected average of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging	an expected average of 6 months

Trial Locations

Locations (1)

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China