DepressionPhase 4NCT00834652
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
A Phase 4 study testing Sertraline and Metformin in people with Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) greater than 28.7
- Positive screening for depression
- Must live within 100 miles of the St. Louis metropolitan area
Who cannot join
- Pregnant or breastfeeding
- Known hypersensitivity to sertraline or metformin
- Recent history of heart attack or unstable heart disease
- Severe liver disease or kidney impairment, defined by a serum creatine level above 3 mg/dL
- Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol or drug dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent
This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.
Read the detailed description
Current depression treatments are not effective for approximately one-half of overweight people, and depression eventually returns in approximately one-third of those overweight people whose initial treatment is effective. One possible reason for these treatment failures is that overweight people often experience a condition called insulin resistance (IR), which can lead to type 2 diabetes, an associated disease that might also affect depression treatment. IR results in elevated blood sugar levels that may interfere with medications used to treat depression. Metformin, a medication commonly used to treat diabetes, reduces blood sugar levels. This study will examine whether taking metformin with the antidepressant medication sertraline will enhance the effectiveness of sertraline in people who are overweight and depressed.
Participation in this study will last a total of 16 weeks and will include baseline testing and ten scheduled study visits. Participants will be randomly assigned to receive either sertraline and metformin or sertraline and placebo on a daily basis. The baseline visit will include the following tests and measures: an electrocardiogram (EKG), which will measure the electrical activity in the heart; an oral glucose tolerance test (OGTT), which will measure how a person's body breaks down glucose; a blood test, which will measure lipids, glycosylated hemoglobin (A1C), and other cardiometabolic risk factors; a dual energy x-ray absorptimetry (DEXA) scan, which will measure body fat; a pregnancy test for women; measurements of vital signs, height, weight, waist-to-hip ratio, and waist circumference; and questionnaires concerning health, medication use, physical activity, diet, and mood. Some of the questionnaires will be administered through interviews with a researcher. During the study visits, which will occur every 2 weeks, participants will complete questionnaires, unused medication will be collected, and new medication will be handed out. At Week 8, participants will provide an additional blood sample by finger stick.
- Conditions
- Depression
- Being tested
- Sertraline, Metformin
- Keywords
- Metabolic Diseases, Depressive Disorder, Major, Depressive Disorder, Glucose Metabolism Disorders, Depression Recurrence
- Medical subject headings
- Depression, Metabolic Diseases, Depressive Disorder, Major, Depressive Disorder, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
50 mg once a day, which may be increased to 200 mg once a day
MetforminDrug
Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive sertraline and metformin. Receives: Drug: Sertraline; Drug: Metformin |
| 2 | Placebo comparator | Participants will receive sertraline and placebo. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Beck Depression Inventory-II Scores Over 16 Weeks
Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment.
Measured: Measured at Baseline and 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startSep 2007
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Patrick J. Lustman, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834652
- Sponsor's protocol ID
- R01MH081150
- Other IDs
- R01MH081150, DAHBR 96-BHC
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2009
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Depression Treatment Outcomes With an Insulin-Sensitizing Agent
- ClinicalTrials.gov ID
- NCT00834652
- Acronym / sponsor ID
- R01MH081150
- Conditions
- Depression
- Keywords
- Metabolic Diseases, Depressive Disorder, Major, Depressive Disorder, Glucose Metabolism Disorders, Depression Recurrence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.
Detailed description
Current depression treatments are not effective for approximately one-half of overweight people, and depression eventually returns in approximately one-third of those overweight people whose initial treatment is effective. One possible reason for these treatment failures is that overweight people often experience a condition called insulin resistance (IR), which can lead to type 2 diabetes, an associated disease that might also affect depression treatment. IR results in elevated blood sugar levels that may interfere with medications used to treat depression. Metformin, a medication commonly used to treat diabetes, reduces blood sugar levels. This study will examine whether taking metformin with the antidepressant medication sertraline will enhance the effectiveness of sertraline in people who are overweight and depressed.
Participation in this study will last a total of 16 weeks and will include baseline testing and ten scheduled study visits. Participants will be randomly assigned to receive either sertraline and metformin or sertraline and placebo on a daily basis. The baseline visit will include the following tests and measures: an electrocardiogram (EKG), which will measure the electrical activity in the heart; an oral glucose tolerance test (OGTT), which will measure how a person's body breaks down glucose; a blood test, which will measure lipids, glycosylated hemoglobin (A1C), and other cardiometabolic risk factors; a dual energy x-ray absorptimetry (DEXA) scan, which will measure body fat; a pregnancy test for women; measurements of vital signs, height, weight, waist-to-hip ratio, and waist circumference; and questionnaires concerning health, medication use, physical activity, diet, and mood. Some of the questionnaires will be administered through interviews with a researcher. During the study visits, which will occur every 2 weeks, participants will complete questionnaires, unused medication will be collected, and new medication will be handed out. At Week 8, participants will provide an additional blood sample by finger stick.
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 |
|---|---|---|
| 1 | Experimental | Drug: Sertraline, Drug: MetforminParticipants will receive sertraline and metformin. |
| 2 | Placebo comparator | Drug: SertralineParticipants will receive sertraline and placebo. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) greater than 28.7
- Positive screening for depression
- Must live within 100 miles of the St. Louis metropolitan area
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding
- Known hypersensitivity to sertraline or metformin
- Recent history of heart attack or unstable heart disease
- Severe liver disease or kidney impairment, defined by a serum creatine level above 3 mg/dL
- Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol or drug dependence
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 |
|---|---|---|
| SertralineAlso: Zoloft50 mg once a day, which may be increased to 200 mg once a day | Drug | 1, 2 |
| MetforminStarting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily | Drug | 1 |
Primary outcome
Change of Beck Depression Inventory-II Scores Over 16 Weeks
Time frame: Measured at Baseline and 16 Weeks
Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrick J. Lustman, PhD principal investigator
Washington University School of Medicine
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 Sertraline and Metformin in people with Depression, run by Washington University School of Medicine at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 10 Sep 2018. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 28 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Beck Depression Inventory-II Scores Over 16 Weeks (time frame: Measured at Baseline and 16 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 10 Sep 2018.