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

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive-Behavior Therapy; Drug: SSRI antidepressants

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chun Wang, doctor; Phone Number: 86 15850566376; Email: fm51109@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Nanjing Brain Hospital
      • Principal Investigator: Chun Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SSRI antidepressants; treatment by SSRI antidepressant	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.; Other Names: fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa); escitalopram (Lexapro); fluvoxamine (Luvox)
Experimental: Cognitive-Behavior Therapy group; treatment with Cognitive-Behavior Therapy	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; Other Names: cognitive behavioural therapy（CBT）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Magnetic Resonance Imaging	an expected average of 6 months

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Principal Investigator: Chun Wang, doctor, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 24, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; major depressive disorder; Cognitive-Behavior Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Sertraline; Citalopram; Paroxetine; Fluoxetine; Fluvoxamine; Antidepressive Agents
• Other Study ID Numbers: QYK09184