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

NCT ID: NCT01460212

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive-Behavior Therapy group

treatment with Cognitive-Behavior Therapy

Group Type EXPERIMENTAL

Cognitive-Behavior Therapy

Intervention Type BEHAVIORAL

The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory

SSRI antidepressants

treatment by SSRI antidepressant

Group Type ACTIVE_COMPARATOR

SSRI antidepressants

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Other Intervention Names

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fluoxetine (Prozac) sertraline (Zoloft) paroxetine (Paxil) citalopram (Celexa) escitalopram (Lexapro) fluvoxamine (Luvox) cognitive behavioural therapy(CBT)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chun Wang

The attending physician, Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Locations

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Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chun Wang, doctor

Role: CONTACT

86 15850566376

Other Identifiers

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QYK09184

Identifier Type: -

Identifier Source: org_study_id

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