NCT01977378

Brief Summary

A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with major depressive disorder.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

October 30, 2013

Last Update Submit

October 30, 2013

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

    Baseline to Week 10

Secondary Outcomes (6)

  • Change From Baseline on the Clinical Global Impression Scale

    Baseline to Week 10

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

    Baseline to Week 10

  • Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10

    Baseline to Week 10

  • Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)

    Baseline to Week 10

  • Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)

    Baseline to Week 10

  • +1 more secondary outcomes

Study Arms (2)

Sustained-Release Desvenlafaxine Hydrochloride

EXPERIMENTAL

50-100mg/d

Drug: Sustained-Release Desvenlafaxine Hydrochloride

Sustained-Release Venlafaxine Hydrochloride

ACTIVE COMPARATOR

75-225mg/d

Drug: Sustained-Release Venlafaxine Hydrochloride

Interventions

Sustained-Release Desvenlafaxine HydrochlorideDRUG
Sustained-Release Desvenlafaxine Hydrochloride
Sustained-Release Venlafaxine HydrochlorideDRUG
Sustained-Release Venlafaxine Hydrochloride

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with primary diagnosis of Major Depressive Disorder
  • Aged from 18 years to 65 years
  • A primary diagnosis of Major Depressive Disorder based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of ≧ 20
  • Clinical Global Impressions Scale-Severity (CGI-S) score of ≧4

You may not qualify if:

  • Known hypersensitivity to desvenlafaxine or venlafaxine
  • Significant risk of suicide based on clinical judgment
  • Women who were pregnant,breast-feeding,or planning to become pregnant during study
  • Had a history of seizure disorder
  • History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs
  • Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Beijing An Ding Hospital

Beijing, 100088, China

RECRUITING

Beijing HuiLongGuan Hospital

Beijing, 100096, China

RECRUITING

The Shanghai Mental Health

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Huafang Li, Professor

    The Shanghai Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huafang Li, Professor

CONTACT

86-021-34773128lhlh_5@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Last Updated

November 6, 2013

Record last verified: 2013-10

Locations

CN(6)