DepressionPhase 2/3NCT01524497
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
A Phase 2/3 study testing Trazodone in people with Depression, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Trazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Nov 2013
- 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
- Age between 18 and 65, males and females, outpatients or inpatients;
- Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
- Scores > 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
- Symptoms of depression for at least 1 month;
- Patients or their dependents/guardians providing signed informed consent forms.
Who cannot join
- Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
- Depressive episode, with psychotic symptoms;
- Refractory depression;
- Depressive episode secondary to other mental or physical disorders;
- Bipolar disorder;
- Significant reduction in body weight and malnutrition induced by major depression;
- Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.
- Conditions
- Depression
- Being tested
- Trazodone, Placebo
- Keywords
- losing interest and feelings of guilt, poor concentration, loss of appetite, suicide
- Medical subject headings
- Depression, Anorexia, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
75mg tablet/150 mg tablet
PlaceboDrug
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Active comparator | Not described Receives: Drug: Trazodone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale-17 score
17-item Hamilton Depression Rating scale were evaluated at the basemline and six weeks after treatment, the changes were recorded and used as primary outcome measurement.
Measured: six weeks
Secondary outcomes (4)
Changes in HAMA-14 score
Change from baseline in HAMA-14 score at Visit 6/final visit
Measured: Six weeks
CGI-Severity of illness and CGI-Global improvement
CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
Measured: Six weeks
Changes in evaluation of sleep quality and sexual dysfunction
change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit
Measured: Six weeks
Rate changes of responders/patients
rate of responders, defined as patients with a 50% improvement from baseline in the HAMD score at Visit6/final visit;or rate of patients with remission, defined as patients with HAMD score ≤7 at Visit 6/final visit.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin LI, Ph.D., Study director, Lee's Pharmaceutical company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524497
- Sponsor's protocol ID
- Trazodone_1
- Status last verified
- Oct 2014
- First submitted
- 13 Jan 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT01524497
- Acronym / sponsor ID
- Trazodone_1
- Conditions
- Depression
- Keywords
- losing interest and feelings of guilt, poor concentration, loss of appetite, suicide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Feb 2012 (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.
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Active comparator | Drug: Trazodone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65, males and females, outpatients or inpatients;
- Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
- Scores > 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
- Symptoms of depression for at least 1 month;
- Patients or their dependents/guardians providing signed informed consent forms.
Key exclusion criteria (7 listed)
- Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
- Depressive episode, with psychotic symptoms;
- Refractory depression;
- Depressive episode secondary to other mental or physical disorders;
- Bipolar disorder;
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 |
|---|---|---|
| Trazodone75mg tablet/150 mg tablet | Drug | Trazodone |
| PlaceboReference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug) | Drug | Placebo |
Primary outcome
Change in Hamilton Depression Rating Scale-17 score
Time frame: six weeks
17-item Hamilton Depression Rating scale were evaluated at the basemline and six weeks after treatment, the changes were recorded and used as primary outcome measurement.
4 secondary outcomes
Changes in HAMA-14 score
Time frame: Six weeks
CGI-Severity of illness and CGI-Global improvement
Time frame: Six weeks
Changes in evaluation of sleep quality and sexual dysfunction
Time frame: Six weeks
Rate changes of responders/patients
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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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.
Benjamin LI, Ph.D. study director
Lee's Pharmaceutical company
1 site 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 Trazodone in people with Depression, run by Lee's Pharmaceutical Limited at 1 site 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: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-17 score (time frame: six weeks). 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 16 Oct 2014.