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Study of Desvenlafaxine in Treating Major Depressive Disorder.

NCT ID: NCT04364997

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2021-09-22

Brief Summary

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The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder.

Detailed Description

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This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder. A total of 400 subjects will be randomly allocated to experimental arm (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine hydrochloride enteric-coated capsule) in a 1:1 ratio.

Conditions

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Major Depressive Disorder

Keywords

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Major Depressive Disorder Desvenlafaxine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desvenlafaxine Succinate Sustained-Release

Group Type EXPERIMENTAL

Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Intervention Type DRUG

Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.

Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Intervention Type DRUG

Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.

Duloxetine Hydrochloride Enteric-coated

Group Type ACTIVE_COMPARATOR

Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule

Intervention Type DRUG

Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,

Duloxetine Hydrochloride Enteric-coated Capsule

Intervention Type DRUG

Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.

Interventions

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Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.

Intervention Type DRUG

Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule

Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,

Intervention Type DRUG

Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.

Intervention Type DRUG

Duloxetine Hydrochloride Enteric-coated Capsule

Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 ≤ age ≤ 65 years old, male or female;
* Outpatients and inpatients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and Neuropsychiatric Interview5.0.0 (MINI5.0.0) for a primary diagnosis of Major Depressive Disorder(MDD), single or recurrent episode and measured by the Mini-International Neuropsychiatric Interview5.0.0 (MINI5.0.0) as active stage.
* Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of \>= 18.

Exclusion Criteria

* Hamilton Rating Scale for Anxiety (HAM-A) total score of \> 14.
* Refractory depression: Ineffective after adequate treatment with two or more antidepressants.
* Current or previous diagnosis of Axis I with DSM-IV other than depression.
* Significant risk of suicide based on clinical judgment or HAM-D 17, Suicide attempt in the past 6 months.
* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xuefang Xia

Role: STUDY_CHAIR

Department of Medicine, CSPC Clinical Development Division

Locations

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Beijing Anding Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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HF124-CSP-001

Identifier Type: -

Identifier Source: org_study_id