NCT03623711

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yuqi Cheng · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

about 150 depression patients were divided into three subgroups, for each group was treated by one antidepressant eg.escitalopram,duloxetine,bupropion.Brain magnetic resonance imaging data were conducted for all patients at baseline, 1 days, 14 days and 12 weeks after treatment. The blood concentration detection, symptom change, cognitive function tests were also conducted. combined with these results the investigators aim to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms and to explore different mechanisms of brain function for effective or ineffective drug response

Conditions

• Major Depressive Disorder
• Depression, Unipolar

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-08-09
• Last updated: 2019-09-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study