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Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging:A Comparative Longitudinal Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01831440
Enrollment
200
Registered
2013-04-15
Start date
2011-01-31
Completion date
2014-12-31
Last updated
2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

depression, remission, Pharmacotherapy, psychotherapy, neuroimaging, psychology

Brief summary

The purpose of this study is to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions. The investigators suppose that even the patient is well-treated by drug,there are still many residual symptoms,and they also exist different degree of damage in the structure and functions of brain. CBT could help them obtain better recovery,especially in psychosocial functions.

Detailed description

Objective:At present, clinical remission of depression is defined as a final HAMD score of less than 7. However, in clinical practice, the psychosocial functions of patients who reach remission are far from complete recovery. The recovery of psychosocial functions lags behind the disappearance of symptoms.so,we aim to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions. Method:200 MDD patients who met the inclusion criteria were randomly divided into CBT group and control group.All of subjects would complete the psychological assessment at 0,1st,2nd,6th and 12th months for CBT group and 0,2nd,12th months for control group.ALL participants would undergo magnetic resonance imaging at 0,2nd,12th months.The scanning sequence is 3D,resting-state,task-state and diffusion tensor imaging(DTI).During the magnetic resonance imaging(MRI) scans, subjects performed the facial and gender recognition tasks with three different facial stimuli(positive/neutral/negative).

Interventions

BEHAVIORALmedicine combined CBT

medicine:Clinical routine antidepressant treatment CBT:During the treatment period,weekly for 8 weeks,and monthly for the maintenance phase.Therapists receive group supervision monthly.

Participants receive only clinical routine antidepressant treatment,Which 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.

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Clinical diagnosis of major depressive disorder (MDD) * Hamilton Rating Scale for Depression(HAMD) less than 7

Exclusion criteria

* Bipolar disorder * Substance dependence * Neurological disorder or other mental disorder * Severe body disease

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Rating Scale for Depression (HAMD)one yearThe 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms.remission of depression is defined as a final HAMD score of less than 7.

Secondary

MeasureTime frameDescription
Magnetic Resonance Imagingone yearScanning sequency:3D、resting-state、task-state、Diffusion Tensor Imaging(DTI) Task:explicit and implicit emotional processes.
The Beck Depression Inventory (BDI)one yearThe Beck Depression Inventory (BDI), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
Generic Quality of Life Inventory-74one yearGeneric Quality of Life Inventory-74(GQOLI-74)created by Dr.Yang Desen and Dr. Li Lingjiang in 1998. It will be used for measuring the quality of life,efficacy and side effect.

Countries

China

Contacts

Primary ContactMa Hui
mahui_njmu@126.com025-82296357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026