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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03148522
Other study ID # 81630031
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 30, 2022

Study information

Verified date December 2019
Source Peking University
Contact Ji-Tao Li, MD
Phone 010-62723742
Email ljt_102124@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Major depressive disorder (MDD) is a high-disabling disease. But its etiology and pathogenesis is not clear, and early recognition, diagnosis and treatment still has many challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core symptom of MDD, especially in patients with melancholic features. Our previous studies and studies abroad have shown that MDD patients had functional abnormality in reward circuit. The abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens - ventral tegmental area were closely associated with the development of MDD, and is an important neural basis of anhedonia. This study would take the reward circuit as mainline to carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would collect MDD patients with melancholic features and other populations with reward dysfunction. The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods would be mainly used in this study. The functional connectivity of reward regions, such as the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also investigate the effect of genetic and environmental factors on reward function of MDD and its biological basis. Finally, through modulating the reward circuit activity using animal experiments, we would verify and investigate reward dysfunction of MDD and its biological mechanisms. The project is expected to provide for new evidence for the establishment of reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- first-episode, drug naive melancholic depression; remitted depression; schizophrenia patients; first-degree relatives of depressed patients.

Exclusion Criteria:

- major somatic diseases; DSM-IV axis I other mental illness; personality disorder, mental retardation; drug and / or alcohol dependence; serious suicidal tendencies or suicidal behavior; pregnant or lactating women; MRI contraindications.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Escitalopram
receive escitalopram
Duloxetine
receive duloxetine
Mirtazapine
receive mirtazapine

Locations

Country Name City State
China Yun-Ai SU Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression remission defined by Hamilton Rating Scale for Depression < 7 8 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03148509 - A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway Phase 4