Study of Desvenlafaxine in Treating Major Depressive Disorder.

Major Depressive Disorder Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Double-simulation, Duloxetine Hydrochloride Enteric-coated Positive-control Phase III Study of Desvenlafaxine Succinate Sustained-Release in the Treatment of Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364997
• Other study ID #: HF124-CSP-001
• Status: Completed
• Phase: Phase 3
• Start date: June 18, 2020
• Est. completion date: September 22, 2021

Study information

• Verified date: December 2021
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: September 22, 2021
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anding Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate	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. A response is defined as = 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.	Baseline to Week 8
Secondary	Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate	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. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of = 7.	Baseline to Week 8
Secondary	Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.	Baseline to Week 8
Secondary	Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)	Clinical Global Impression Scale-Improvement (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.	Baseline to Week 8
Secondary	Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)	Clinical Global Impression-Severity Score (CGI-S): 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.	Baseline to Week 8
Secondary	Change From Baseline on the Visual Analog Scale (VAS) for Pain	The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.	Baseline to Week 8