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

NCT ID: NCT03148522

Last Updated: 2019-12-13

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

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diagnosis and Treatment of Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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escitalopram

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

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

receive escitalopram

duloxetine

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

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

receive duloxetine

mirtazapine

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

Group Type EXPERIMENTAL

Mirtazapine

Intervention Type DRUG

receive mirtazapine

Interventions

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Escitalopram

receive escitalopram

Intervention Type DRUG

Duloxetine

receive duloxetine

Intervention Type DRUG

Mirtazapine

receive mirtazapine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Si Tianmei

Director of Clinical Psychopharmacology Division Institute of Mental Health, Peking University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yun-Ai SU

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ji-Tao Li, MD

Role: CONTACT

Phone: 010-62723742

Email: [email protected]

Facility Contacts

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Yun-Ai Su, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35788366 (View on PubMed)

Other Identifiers

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81630031

Identifier Type: -

Identifier Source: org_study_id