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

Primary Purpose

Major Depressive Disorder, Depression, Unipolar

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Duloxetine
Bupropion
Healthy control
Sponsored by
Yuqi Cheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, Magnetic Resonance Imaging, Antidepressant Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Escitalopram group

Duloxetine group

Bupropion group

Healthy control

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

change of functional magnetic resonance imaging (fMRI) after medication
change of fMRI after medication

Secondary Outcome Measures

Full Information

First Posted
July 14, 2017
Last Updated
September 14, 2019
Sponsor
Yuqi Cheng
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1. Study Identification

Unique Protocol Identification Number
NCT03623711
Brief Title
A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression
Official Title
A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuqi Cheng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression, Unipolar
Keywords
major depressive disorder, Magnetic Resonance Imaging, Antidepressant Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram group
Arm Type
Experimental
Arm Description
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.
Arm Title
Duloxetine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Bupropion group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
participants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
cymbalta
Intervention Description
participants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
bupropion hydrochloride tablets
Intervention Description
participants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Healthy control
Other Intervention Name(s)
placebo tablets
Intervention Description
Healthy control take placebo tablets
Primary Outcome Measure Information:
Title
change of functional magnetic resonance imaging (fMRI) after medication
Description
change of fMRI after medication
Time Frame
at baseline, 1 days, 14 days and 12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqi Cheng, PhD
Phone
13888122013
Email
yuqicheng@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqi Cheng, PhD
Phone
+86-0871-65324888
Email
yuqicheng@126.com
First Name & Middle Initial & Last Name & Degree
Yuqi Cheng
Phone
13888122013
Email
yuqicheng@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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