Depressive Disorder, MajorNCT00451490
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
A study testing Agomelatine and Fluoxentine in people with Depressive Disorder, Major, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Agomelatine and Fluoxentine
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2006to Dec 2007
- Phase
- Interventional
- 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
- Asian patients
- Male or female
- 18 to 65 years outpatients
- DSM-IV-TR criteria for Major Depressive Disorder
Who cannot join
- Patients with cardiac conditions and other physical conditions contraindicated for drug study
- Shift worker
- Patients known to be non-responders to fluoxetine treatment
- Pregnancy, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.
Read the detailed description
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.
- Conditions
- Depressive Disorder, Major
- Being tested
- Agomelatine, Fluoxentine
- Keywords
- agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgomelatineDrug
FluoxentineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire
Secondary outcomes (1)
heart rate variability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startOct 2006
- Study completionDec 2007 (estimated)
Why it stopped: This study not get the approval by the drug company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by National Taiwan 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Chih Tseng, MD, Principal investigator, National Taiwan Univetsity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451490
- Sponsor's protocol ID
- 200610027R
- Status last verified
- Jan 2007
- First submitted
- 21 Mar 2007
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00451490
- Acronym / sponsor ID
- 200610027R
- Conditions
- Depressive Disorder, Major
- Keywords
- agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study not get the approval by the drug company
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Dec 2007 (estimated)
- First posted
- 23 Mar 2007 (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.
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.
Detailed description
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Asian patients
- Male or female
- 18 to 65 years outpatients
- DSM-IV-TR criteria for Major Depressive Disorder
Key exclusion criteria (4 listed)
- Patients with cardiac conditions and other physical conditions contraindicated for drug study
- Shift worker
- Patients known to be non-responders to fluoxetine treatment
- Pregnancy, 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 |
|---|---|---|
| Agomelatine | Drug | – |
| Fluoxentine | Drug | – |
Primary outcome
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire
1 secondary outcome
heart rate variability
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2008.
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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.
Mei-Chih Tseng, MD principal investigator
National Taiwan Univetsity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agomelatine and Fluoxentine in people with Depressive Disorder, Major, run by National Taiwan 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 4 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: withdrawn, as of the sponsor's last update on 8 Jan 2008. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
the Pittsburgh Sleep Quality Index. The study lists 2 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 8 Jan 2008.