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

NCT03623711 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 81660237
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Depression, Unipolar

Keywords

major depressive disorder; Magnetic Resonance Imaging; Antidepressant Treatment

Outcome Measures

Primary Outcomes (1)

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

  change of fMRI after medication

  at baseline, 1 days, 14 days and 12 weeks after treatment

Study Arms (4)

Escitalopram group

EXPERIMENTAL

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

Duloxetine group

EXPERIMENTAL

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

Bupropion group

EXPERIMENTAL

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

Healthy control

PLACEBO COMPARATOR

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

Interventions

Escitalopram DRUG

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

Also known as: Lexapro

Escitalopram group

Duloxetine DRUG

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

Also known as: cymbalta

Duloxetine group

Bupropion DRUG

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

Also known as: bupropion hydrochloride tablets

Bupropion group

Healthy control OTHER

Healthy control take placebo tablets

Also known as: placebo tablets

Healthy control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuqi Cheng: lead

Study Sites (1)

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Escitalopram; Duloxetine Hydrochloride; Bupropion

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones

Central Study Contacts

Yuqi Cheng, PhD

CONTACT

13888122013; yuqicheng@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 9, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

CN (1)