DepressionPhase 1CHIMENCT00208117
A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
A Phase 1 study testing Sertraline (Zoloft) and Simvastatin (Zocor) in people with Depression and Coronary Artery Disease (CAD), run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)
- What is being tested?
- Sertraline (Zoloft) and Simvastatin (Zocor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jan 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 60
- Mild depression
- Inflammatory markers: CRP > 2
Who cannot join
- Non-English or Non-Spanish speakers
- Active suicidal or homicidal ideation
- Current alcohol or other substance abuse
- Psychotic features
- Current personality disorder
- History of bipolar depressive disorder
Show all 20Show fewer
- Any current psychotic disorder
- Current major depressive disorder
- Current depression treatment or treatment within preceding 6 weeks
- History of chronic liver and/or renal disease
- Current use or contraindication to any of the tested medications
- Absence of a response to a previous adequate trial of any of the tested medications
- Pregnant or lactating women
- History of coronary artery disease
- Current use of statins
- Current, regular aspirin use
- Antibiotic use within the previous four weeks
- History of diabetes
- Inflammatory diseases
- Meets NCEP guidelines for cholesterol lowering therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Department of General Medicine
New York, New York, 10032
About this study
Official title: A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.
Read the detailed description
Depressive symptoms and inflammatory markers have both been proposed as measures that indicate/precede coronary artery disease (CAD). However, no controlled research study has tested the impact of these two candidate CAD risk factors within the same design to see the directionality of their influence. This study will explore if simvastatin reduces depressive symptoms and if sertraline reduces C-Reactive protein (CRP). Additionally, the recruitment process will help determine the feasibility of a larger trial, powered for significance testing. Three hundred and seventy-five participants will be consented and screened for this study. We expect forty-two otherwise healthy outpatients to have both elevated symptoms and high CRP levels, and be willing to be randomly assigned to sertraline, an antidepressant, simvastatin, a drug with anti-inflammatory properties, or a placebo for 8 weeks. Depressive symptoms and inflammatory indicators will be assessed before treatment (screening and baseline), mid-treatment (after 4 weeks), post-treatment (after 8 weeks), and a follow-up visit (after 12 weeks), using blood tests and depression interviews. We expect that both inflammation and depressive symptoms may be reduced by both medications, but the number of subjects needed to test this hypothesis is not yet known. Hence, this pilot study will be conducted. Knowledge about the inter-dependency of these two CAD risk factors allows the most promising future observational/intervention studies to be designed and conducted.
- Being tested
- Sertraline (Zoloft), Simvastatin (Zocor)
- Keywords
- depression, inflammation, heart disease, randomized clinical trial, sertraline, simvastatin, placebo
- Medical subject headings
- Depression, Coronary Artery Disease, Acute Coronary Syndrome, Inflammation, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline (Zoloft)Drug
Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If adverse events occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained.
Simvastatin (Zocor)Drug
The placebo drug will be administered for 8 weeks. To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If AEs occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained. The psychiatry fellow will be responsible for drug administration and will see all patients weekly. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess medical tolerance to the study medications, and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation. Receives: Drug: Sertraline (Zoloft) |
| 2 | Placebo comparator | To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess the medical tolerance to the study medications (including placebo), and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation. Receives: Drug: Simvastatin (Zocor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Unable to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Karina W Davidson, PhD, Principal investigator, Columbia University: Behavioral Cardiovascular Health and Hypertension Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208117
- Sponsor's protocol ID
- 4976 (Davidson)
- Acronym
- CHIME
- Status last verified
- May 2012
- First submitted
- 15 Sep 2005
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease
- ClinicalTrials.gov ID
- NCT00208117
- Acronym / sponsor ID
- CHIME / 4976 (Davidson)
- Keywords
- depression, inflammation, heart disease, randomized clinical trial, sertraline, simvastatin, placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll subjects
- Enrolment
- 7 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Apr 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Sep 2005 (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 examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.
Detailed description
Depressive symptoms and inflammatory markers have both been proposed as measures that indicate/precede coronary artery disease (CAD). However, no controlled research study has tested the impact of these two candidate CAD risk factors within the same design to see the directionality of their influence. This study will explore if simvastatin reduces depressive symptoms and if sertraline reduces C-Reactive protein (CRP). Additionally, the recruitment process will help determine the feasibility of a larger trial, powered for significance testing. Three hundred and seventy-five participants will be consented and screened for this study. We expect forty-two otherwise healthy outpatients to have both elevated symptoms and high CRP levels, and be willing to be randomly assigned to sertraline, an antidepressant, simvastatin, a drug with anti-inflammatory properties, or a placebo for 8 weeks. Depressive symptoms and inflammatory indicators will be assessed before treatment (screening and baseline), mid-treatment (after 4 weeks), post-treatment (after 8 weeks), and a follow-up visit (after 12 weeks), using blood tests and depression interviews. We expect that both inflammation and depressive symptoms may be reduced by both medications, but the number of subjects needed to test this hypothesis is not yet known. Hence, this pilot study will be conducted. Knowledge about the inter-dependency of these two CAD risk factors allows the most promising future observational/intervention studies to be designed and conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sertraline (Zoloft)Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If AEs occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained. The psychiatry fellow will be responsible for drug administration and will see all patients weekly. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess medical tolerance to the study medications, and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation. |
| 2 | Placebo comparator | Drug: Simvastatin (Zocor)To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills. All randomized patients will also be seen at the mid-treatment, post-treatment, and follow-up visits by the study psychiatrist to determine depression symptom severity (HAM-D), assess the medical tolerance to the study medications (including placebo), and ensure patient psychiatric safety. The study psychiatrist will be blinded to treatment allocation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 60
- Mild depression
- Inflammatory markers: CRP > 2
Key exclusion criteria (20 listed)
- Non-English or Non-Spanish speakers
- Active suicidal or homicidal ideation
- Current alcohol or other substance abuse
- Psychotic features
- Current personality disorder
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 |
|---|---|---|
| Sertraline (Zoloft)Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If adverse events occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained. | Drug | 1 |
| Simvastatin (Zocor)The placebo drug will be administered for 8 weeks. To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills. | Drug | 2 |
Primary outcome
Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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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.
Karina W Davidson, PhD principal investigator
Columbia University: Behavioral Cardiovascular Health and Hypertension Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sertraline (Zoloft) and Simvastatin (Zocor) in people with Depression and Coronary Artery Disease (CAD), run by New York State Psychiatric Institute 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 20 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: stopped early, as of the sponsor's last update on 31 May 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
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?
Score on Beck Depression Inventory and C-Reactive Protein Level at weeks 4, 8, and 12 (time frame: 3 months). 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 31 May 2012.