Major Depressive Disorder
Conditions
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.
Interventions
DRUGSustained-Release Desvenlafaxine Hydrochloride
DRUGSustained-Release Venlafaxine Hydrochloride
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) | Baseline to Week 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 on the Clinical Global Impression Scale | Baseline to Week 10 | — |
| Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI) | Baseline to Week 10 | — |
| Number of Participants in Remission Based on the HAM-D17 at Week 10 | Baseline to Week 10 | Remission was defined as a HAM-D17 score of less than or equal to 7. |
| Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline to Week 10 | — |
Countries
China
Contacts
Primary ContactHuafang Li, Professor
Outcome results
None listed