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

Sponsor

Yuqi Cheng (Other)

Overall Status

Recruiting

CT.gov ID

NCT03623711

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Depression, Unipolar	Drug: Escitalopram Drug: Duloxetine Drug: Bupropion Other: Healthy control	Early Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Escitalopram group including 50 patients, dosage:start 10mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 20mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week.	Drug: Escitalopram participants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks. Other Names: Lexapro
Experimental: Duloxetine group including 50 patients, dosage:start 30mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 60mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline,the investigators will continue to use current dosage until the end of 12 week.	Drug: Duloxetine participants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks. Other Names: cymbalta
Experimental: Bupropion group including 50 patients, dosage:start 75mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week.if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 150mg/day and last 2 weeks, the investigators assess the HAMD score again, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week, but if the reduction rate of HAMD still less than 20% relative to baseline, the participants would withdraw.	Drug: Bupropion participants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks. Other Names: bupropion hydrochloride tablets
Placebo Comparator: Healthy control 50 age-, gender-,education level- and handedness matched healthy control would recruit by an advertisement in the local community and school, and excluding ① with a severe physical disease and/or neurological disease, ②with substance abuse, ③ with a history of brain injury, ④ inability to undergo a MRI scan.	Other: Healthy control Healthy control take placebo tablets Other Names: placebo tablets

Outcome Measures

Primary Outcome Measures

change of functional magnetic resonance imaging (fMRI) after medication [at baseline, 1 days, 14 days and 12 weeks after treatment]
change of fMRI after medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnostic and Statistical Manual (DSM)-IV Major Depression or Dysthymia
Age 18-60
Physically healthy
The score of Hamilton Depression Rating Scale (HAMD)≥18 points
Drug-free

Exclusion Criteria:

Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
History of Psychosis or Epilepsy
Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
Bipolar I
Need for wash-out from effective treatment in order to participate
Pregnant or breastfeeding
High suicide risk
Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
have received regular treatment of electric convulsions, repetitive transcranial magnetic stimulation (rTMS), or systematic psychotherapy within three months