Study of Desvenlafaxine in Treating Major Depressive Disorder.

NCT04364997 | Completed Phase 3

• 1 other identifier: HF124-CSP-001
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Desvenlafaxine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8

  Hamilton Rating Scale for Depression, 17-item is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.

  Baseline to Week 8

Secondary Outcomes (6)

• Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate

  Baseline to Week 8

• Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate

  Baseline to Week 8

• Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

  Baseline to Week 8

• Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)

  Baseline to Week 8

• Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)

  Baseline to Week 8

Study Arms (2)

Desvenlafaxine Succinate Sustained-Release

EXPERIMENTAL

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

Duloxetine Hydrochloride Enteric-coated

ACTIVE COMPARATOR

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

Interventions

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

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

Desvenlafaxine Succinate Sustained-Release

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

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

Duloxetine Hydrochloride Enteric-coated

Duloxetine Hydrochloride Enteric-coated Capsule Placebo DRUG

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

Desvenlafaxine Succinate Sustained-Release

Duloxetine Hydrochloride Enteric-coated Capsule DRUG

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

Duloxetine Hydrochloride Enteric-coated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Anding Hospital

Beijing, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Xuefang Xia

  Department of Medicine, CSPC Clinical Development Division

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: June 18, 2020
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

CN (1)