A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression

NCT03623711 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-09-17

No results posted yet for this study

Summary

Antidepressants is the primary treatment for depression, but only less than 50% of the patients get clinical remission. There is no objective markers to select antidepressants for clinical treatment . Clinical choose usually use experience and waste a lot of time, even the patients cannot be treated timely and effectively. The investigators found that the later antidepressant effect for 8 weeks is related with early brain functional response. Present prospectively drug treatment and follow-up study intends to adopt pharmacological imaging research methods to detect the brain function or structure change of three different mechanisms of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs, escitalopram), serotonin and norepinephrine reuptake inhibitors (SNRIs, duloxetine), norepinephrine and dopamine reuptake inhibitors (NDRIs, bupropion) in depression patients. Brain functional or structural magnetic resonance imaging data were collected at baseline, 1 days, 14 days and 12 weeks after treatment. The investigators want to observe the changes of brain functional networks and structure at different time points, acute and chronic treatment induced during drug treatment. Combined with the blood concentration detection, symptom change, cognitive function tests, the investigators also hope to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms. The second aim is to explore different mechanisms of brain function for effective or ineffective drug response. The results of the study will help to further explain the mechanism of different antidepressants, to facilitate the development of early indicators for drug efficacy and individual treatment decision.

Conditions

Interventions

DRUG

Escitalopram

participants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks.

DRUG

Duloxetine

participants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks.

DRUG

Bupropion

participants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks.

OTHER

Healthy control

Healthy control take placebo tablets

Sponsors & Collaborators

  • Yuqi Cheng

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623711 on ClinicalTrials.gov