Major Depressive DisorderPhase 2/3NCT01977378
A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder
A Phase 2/3 study testing Sustained-Release Desvenlafaxine Hydrochloride and Sustained-Release Venlafaxine Hydrochloride in people with Major Depressive Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sustained-Release Desvenlafaxine Hydrochloride and Sustained-Release Venlafaxine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing An Ding Hospital
Beijing, 100088
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, 100096
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
West China Hospital
Chengdu, Sichuan
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
- Recruiting
The Shanghai Mental Health
Shanghai, 200030
Huafang Li, Professor, 86-021-34773128, lhlh_5@163.com
Huafang Li, Professor
About this study
Official title: A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Sustained-Release Desvenlafaxine Hydrochloride, Sustained-Release Venlafaxine Hydrochloride
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained-Release Desvenlafaxine HydrochlorideDrug
Sustained-Release Venlafaxine HydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Sustained-Release Desvenlafaxine Hydrochloride | Experimental | 50-100mg/d Receives: Drug: Sustained-Release Desvenlafaxine Hydrochloride |
| Sustained-Release Venlafaxine Hydrochloride | Active comparator | 75-225mg/d Receives: Drug: Sustained-Release Venlafaxine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
Measured: Baseline to Week 10
Secondary outcomes (6)
Change From Baseline on the Clinical Global Impression Scale
Measured: Baseline to Week 10
Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale
Measured: Baseline to Week 10
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10
Measured: Baseline to Week 10
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Baseline to Week 10
Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)
Measured: Baseline to Week 10
Number of Participants in Remission Based on the HAM-D17 at Week 10
Remission was defined as a HAM-D17 score of less than or equal to 7.
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huafang Li, Professor, Principal investigator, The Shanghai Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977378
- Sponsor's protocol ID
- DVS20130806
- Status last verified
- Oct 2013
- First submitted
- 30 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01977378
- Acronym / sponsor ID
- DVS20130806
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained-Release Desvenlafaxine Hydrochloride | Experimental | Drug: Sustained-Release Desvenlafaxine Hydrochloride50-100mg/d |
| Sustained-Release Venlafaxine Hydrochloride | Active comparator | Drug: Sustained-Release Venlafaxine Hydrochloride75-225mg/d |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained-Release Desvenlafaxine Hydrochloride | Drug | Sustained-Release Desvenlafaxine Hydrochloride |
| Sustained-Release Venlafaxine Hydrochloride | Drug | Sustained-Release Venlafaxine Hydrochloride |
Primary outcome
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
Time frame: Baseline to Week 10
6 secondary outcomes
Change From Baseline on the Clinical Global Impression Scale
Time frame: Baseline to Week 10
Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale
Time frame: Baseline to Week 10
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10
Time frame: Baseline to Week 10
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline to Week 10
Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)
Time frame: Baseline to Week 10
Number of Participants in Remission Based on the HAM-D17 at Week 10
Time frame: Baseline to Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang Li, Professor principal investigator
The Shanghai Mental Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sustained-Release Desvenlafaxine Hydrochloride and Sustained-Release Venlafaxine Hydrochloride in people with Major Depressive Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li, Professor (86-021-34773128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) (time frame: Baseline to Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.