Major Depressive DisorderNCT03121573
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
A study testing Duloxetine in people with Major Depressive Disorder, run by Taichung Veterans General Hospital.
Trial summary
The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2014to 17 Jan 2017
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HAMD-17 more than 12 points
- Participants could understand this study and sign permit
- Participants could receive NIRS measurements
- Participants could comply with the protocol of the study
Who cannot join
- alcohol or substance abuse within 3 months of the study
- ever participate other clinical study related to duloxetine
- previous poor treatment effects of duloxetine
- concomitant use of MAOi within 14 days
- concomitant use of Linezolid
- with uncontrolled glaucoma
About this study
The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.
- Conditions
- Major Depressive Disorder
- Being tested
- Duloxetine
- Keywords
- near infrared spectroscopy, NIRS, duloxetine
- 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.
DuloxetineDrug
duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | medication: duloxetine 30 to 60 mg tablets by mouth, QD to BID. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression severity
Hamilton Rating Scale for Depression
Measured: 0-2-4-8-12 weeks
Secondary outcomes (1)
Change in Brain cortical activity
Using Near Infrared Spectroscopy
Measured: 0-2-4-8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start15 Dec 2014
- Primary completion26 Sep 2016
- Study completion17 Jan 2017
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 Taichung Veterans General 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121573
- Sponsor's protocol ID
- SF14216
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
- ClinicalTrials.gov ID
- NCT03121573
- Acronym / sponsor ID
- SF14216
- Conditions
- Major Depressive Disorder
- Keywords
- near infrared spectroscopy, NIRS, duloxetine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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 aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.
Study design
- Primary purpose
- Health services research
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Drug: Duloxetinemedication: duloxetine 30 to 60 mg tablets by mouth, QD to BID. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HAMD-17 more than 12 points
- Participants could understand this study and sign permit
- Participants could receive NIRS measurements
- Participants could comply with the protocol of the study
Key exclusion criteria (6 listed)
- alcohol or substance abuse within 3 months of the study
- ever participate other clinical study related to duloxetine
- previous poor treatment effects of duloxetine
- concomitant use of MAOi within 14 days
- concomitant use of Linezolid
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 |
|---|---|---|
| Duloxetineduloxetine 30 to 60 mg tablets by mouth, QD to BID per day, | Drug | intervention |
Primary outcome
Change in Depression severity
Time frame: 0-2-4-8-12 weeks
Hamilton Rating Scale for Depression
1 secondary outcome
Change in Brain cortical activity
Time frame: 0-2-4-8-12 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 20 Apr 2017.
- Individual participant dataSharing planned: No. no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Major Depressive Disorder, run by Taichung Veterans General Hospital.
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 6 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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 Depression severity (time frame: 0-2-4-8-12 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 20 Apr 2017.