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Trial record 2 of 5 for:    Recruiting, Not yet recruiting, Available Studies | "O-desmethylvenlafaxine"

Study of Desvenlafaxine in Treating Major Depressive Disorder.

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ClinicalTrials.gov Identifier: NCT04364997
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo Drug: Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule Drug: Duloxetine Hydrochloride Enteric-coated Capsule Placebo Drug: Duloxetine Hydrochloride Enteric-coated Capsule Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Desvenlafaxine Succinate Sustained-Release 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.

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.

Active Comparator: Duloxetine Hydrochloride Enteric-coated 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,

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




Primary Outcome Measures :
  1. Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 [ Time Frame: Baseline to 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.


Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate [ Time Frame: Baseline to 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. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.

  2. Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate [ Time Frame: Baseline to 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. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.

  3. Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline to Week 8 ]
    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.

  4. Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) [ Time Frame: Baseline to Week 8 ]
    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.

  5. Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) [ Time Frame: Baseline to Week 8 ]
    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.

  6. Change From Baseline on the Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline to Week 8 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364997


Contacts
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Contact: Xuefang Xia 0311-67808812 xiaxuefang@mail.ecspc.com

Locations
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China
Beijing Anding Hospital Recruiting
Beijing, China
Contact: Qian Zhao         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Study Chair: Xuefang Xia Department of Medicine, CSPC Clinical Development Division
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04364997    
Other Study ID Numbers: HF124-CSP-001
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
Major Depressive Disorder
Desvenlafaxine
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents