Major Depressive DisorderPhase 4NCT01699490
Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder
A Phase 4 study testing Fluoxetine + Valsartan in people with Major Depressive Disorder, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. 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?
- Fluoxetine + Valsartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Jul 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- 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 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
Department of Psychiatry, National Cheng-Kung University Hospital
Tainan, 701
Po See Chen, M.D., Ph.D., +886-6-2353535 ext. 5213, chenps@mail.ncku.edu.tw
About this study
Official title: Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder
The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis
Read the detailed description
The prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in MDD patients are necessary.
- Conditions
- Major Depressive Disorder
- Being tested
- Fluoxetine + Valsartan, Fluoxetine + Placebo
- Keywords
- Major Depressive Disorder, Antidepressants, Insulin, Fluoxetine
- Medical subject headings
- Depressive Disorder, Major, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine + ValsartanDrug
Also called Prozac, Diovan
The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
Fluoxetine + PlaceboDrug
Also called Prozac
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine + Valsartan | Experimental | 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 60 mg.
Add-on treatment to 40 mg per day of valsartan Receives: Drug: Fluoxetine + Valsartan |
| Fluoxetine + Placebo | Active comparator | 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 60 mg.
Add-on treatment to placebo Receives: Drug: Fluoxetine + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Measured: 12 weeks
Secondary outcomes (3)
fasting plasma glucose
Measured: 12 weeks
fasting serum insulin
Measured: 12 weeks
C-reactive Protein, and IL-6
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Po-See, Chen, National Cheng-Kung University Hospital
- Investigators
- Po See Chen, M.D., Ph.D, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699490
- Sponsor's protocol ID
- NSC 101-2314-B-006 -064 -MY3
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2012
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01699490
- Acronym / sponsor ID
- NSC 101-2314-B-006 -064 -MY3
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Antidepressants, Insulin, 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
- National Science and Technology Council, Taiwan
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Oct 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.
The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis
Detailed description
The prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in MDD patients are necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine + Valsartan | Experimental | Drug: Fluoxetine + ValsartanThe 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 60 mg. Add-on treatment to 40 mg per day of valsartan |
| Fluoxetine + Placebo | Active comparator | Drug: Fluoxetine + PlaceboThe 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 60 mg. Add-on treatment to placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 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 |
|---|---|---|
| Fluoxetine + ValsartanAlso: Prozac, DiovanThe curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder. | Drug | Fluoxetine + Valsartan |
| Fluoxetine + PlaceboAlso: ProzacThe curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder. | Drug | Fluoxetine + Placebo |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: 12 weeks
3 secondary outcomes
fasting plasma glucose
Time frame: 12 weeks
fasting serum insulin
Time frame: 12 weeks
C-reactive Protein, and IL-6
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Po See Chen, M.D., Ph.D 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 Fluoxetine + Valsartan in people with Major Depressive Disorder, 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 29 Sep 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 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?
Contact Po See Chen, M.D., Ph.D. (+886-6-2353535 ext. 5213, chenps@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (time frame: 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 29 Sep 2014.