A Diagnosis and Treatment Optimization Study of Depression Based on the Neurological Mechanism of Reward System

NCT03148522 | Unknown

• 1 other identifier: 81630031
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diagnosis and Treatment of Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

  remission defined by Hamilton Rating Scale for Depression \< 7

  8 weeks

Study Arms (3)

escitalopram

EXPERIMENTAL

Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.

Drug: Escitalopram

duloxetine

EXPERIMENTAL

Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.

Drug: Duloxetine

mirtazapine

EXPERIMENTAL

Eligible patients were assigned to mirtazapine treatment based on investigators' clinical practice.

Drug: Mirtazapine

Interventions

Escitalopram DRUG

receive escitalopram

escitalopram

Duloxetine DRUG

receive duloxetine

duloxetine

Mirtazapine DRUG

receive mirtazapine

mirtazapine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Yun-Ai SU

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Lin J, Su Y, Rizvi SJ, Jagoda J, Li J, Wu Y, Dai Y, Zhang Y, Kennedy SH, Si T. Define and characterize the anhedonia in major depressive disorder: An explorative study. J Affect Disord. 2022 Sep 15;313:235-242. doi: 10.1016/j.jad.2022.06.082. Epub 2022 Jul 3.

  PMID: 35788366 DERIVED

MeSH Terms

Conditions

Disease

Interventions

Escitalopram; Duloxetine Hydrochloride; Mirtazapine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Ji-Tao Li, MD

CONTACT

010-62723742; ljt_102124@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Psychopharmacology Division Institute of Mental Health, Peking University

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: June 1, 2017
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)