Major Depressive DisorderPhase 4NCT01204086
Pharmacogenomics Studies of Antidepressants
A Phase 4 study testing Venlafaxine and Fluoxetine in people with Major Depressive Disorder and Antidepressive Agents, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics
- What is being tested?
- Venlafaxine and Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2007to Feb 2011
- Phase
- Phase 4
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 16-65 years old
- Signed informed consent by patient or legal representative
- Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
- A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry
Who cannot join
- monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
- A DSM-IV diagnosis of substance abuse within the past three months
- An organic mental disease, mental retardation or dementia
- A serious surgical condition or physical illness
- Patients who were pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Po See Chen, MD, +886-6-2353535 ext. 5213, chenps@mail.ncku.edu.tw
Po See Chen, MD
About this study
The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.
- Conditions
- Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics, Venlafaxine, Fluoxetine
- Being tested
- Venlafaxine, Fluoxetine
- Keywords
- Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine
- 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.
VenlafaxineDrug
The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.
FluoxetineDrug
The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.
| Study group | Role | What they receive |
|---|---|---|
| venlafaxine | Experimental | Not described Receives: Drug: Venlafaxine |
| fluoxetine | Experimental | Not described Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Measured: baseline
Hamilton Depression Rating Scale (HDRS)
Measured: 2 weeks
Hamilton Depression Rating Scale (HDRS)
Measured: 4 weeks
Hamilton Depression Rating Scale (HDRS)
Measured: 6 weeks
Secondary outcomes (4)
C-reactive Protein and IL-6
Measured: baseline
fasting blood glucose, lipid profiles
Measured: baseline
C-reactive Protein and IL-6
Measured: 6 weeks
fasting blood glucose, lipid profiles
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startMar 2007
- Primary completionDec 2010 (estimated)
- Study completionFeb 2011 (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 National Cheng-Kung University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Po See Chen, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204086
- Sponsor's protocol ID
- HR-95-06
- Other IDs
- DOH96-TD-D-113-041
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Studies of Antidepressants
- ClinicalTrials.gov ID
- NCT01204086
- Acronym / sponsor ID
- HR-95-06
- Conditions
- Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics, Venlafaxine, Fluoxetine
- Keywords
- Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 17 Sep 2010 (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.
The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venlafaxine | Experimental | Drug: Venlafaxine |
| fluoxetine | Experimental | Drug: Fluoxetine |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16-65 years old
- Signed informed consent by patient or legal representative
- Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
- A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry
Key exclusion criteria (5 listed)
- monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
- A DSM-IV diagnosis of substance abuse within the past three months
- An organic mental disease, mental retardation or dementia
- A serious surgical condition or physical illness
- Patients who were pregnant or breastfeeding
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 |
|---|---|---|
| VenlafaxineThe initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg. | Drug | venlafaxine |
| FluoxetineThe initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg. | Drug | fluoxetine |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: baseline
Hamilton Depression Rating Scale (HDRS)
Time frame: 2 weeks
Hamilton Depression Rating Scale (HDRS)
Time frame: 4 weeks
Hamilton Depression Rating Scale (HDRS)
Time frame: 6 weeks
4 secondary outcomes
C-reactive Protein and IL-6
Time frame: baseline
fasting blood glucose, lipid profiles
Time frame: baseline
C-reactive Protein and IL-6
Time frame: 6 weeks
fasting blood glucose, lipid profiles
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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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.
National Cheng-Kung University Hospital
Tainan, Taiwan
Po See Chen, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine and Fluoxetine in people with Major Depressive Disorder and Antidepressive Agents, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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 17 Sep 2010. 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 Taiwan. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (time frame: baseline). The study lists 4 primary outcomes in all. 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 17 Sep 2010.