Acute Coronary SyndromePhase 1/2CODIACSNCT01032018
Comparison of Depression Interventions After Acute Coronary Syndrome
A Phase 1/2 study testing Problem Solving Therapy and Sertraline, citalopram, or bupropion in people with Acute Coronary Syndrome and Depression, run by Columbia University at 5 sites in United States.
Trial summary
Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Depression
- What is being tested?
- Problem Solving Therapy and Sertraline, citalopram, or bupropion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 1/2
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized for ACS defined as unstable angina or MI
- BDI greater or equal to 10 and < 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion
- Age at least 35 years
- Fluent in English or Spanish
- Able to complete baseline assessment within 2-6 months of index ACS event
- Able and willing to provide informed consent
Who cannot join
- Presence of non-cardiac condition likely to terminate fatally within 1 year
- Inaccessibility for intervention or follow-up (e.g., plans to move from the area)
- Cognitive impairment
- Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours)
- Suicidal ideation
- Major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder
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- Active substance abuse or dependency
- Chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate"…[eGFR] < 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, GI bleeding)
- Participation in another clinical trial for the treatment of depression.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
Yale University
New Haven, Connecticut, 06520
Columbia University Medical Center
New York, New York, 10032
Washington University
St Louis, Missouri, 63130
Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks
Yardley, Pennsylvania, 19067
About this study
Official title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.
The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.
- Conditions
- Acute Coronary Syndrome, Depression
- Being tested
- Problem Solving Therapy, Sertraline, citalopram, or bupropion, Standard care
- Keywords
- Acute coronary syndrome, Depression, Satisfaction with care
- Medical subject headings
- Acute Coronary Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
Problem Solving Therapy (PST) will be administered by a trained provider. The concepts of PST will be taught to the participant in the first session and reinforced across subsequent sessions. Sessions will last between 30 and 60 minutes each and continue weekly for the duration of the study (6 months).
Sertraline, citalopram, or bupropionDrug
Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week,with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST-PC after 2-4 weeks and 'restart' step 1.
Sertraline: 25-150qam Citalopram: 10-40qam Bupropion: 100-450qam
Standard careOther
Participants will receive standard of care from the current physicians
| Study group | Role | What they receive |
|---|---|---|
| Referred Care | Active comparator | Immediately after the initial post-ACS screening, the participant's physician will be notified in writing if the participant is depressed according to the BDI. Depending upon the physician's own evaluation of the participant, he or she may elect to defer depression treatment, initiate it, or to refer the patient to a mental health specialist. Receives: Other: Standard care |
| Stepped Care | Experimental | Stepped Care participants will be given a description of the choices available in this arm, including choosing antidepressant medication and/or telephone-based, Problem-Solving Therapy (PST). If the patient is randomized to Stepped Care, their physician will be informed that depression treatment is being provided by the trial. Patients will select their preferred treatment approach. Depression symptoms will be monitored to determine whether the patient is improving relative to his/her baseline score. Relapse monitoring and maintenance therapy will continue for the duration of the study. Receives: Behavioral: Problem Solving Therapy; Drug: Sertraline, citalopram, or bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Reduction
Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.
Measured: Change from depression at baseline to depression at 6-months
Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJul 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, Emory University, Yale University, Washington University School of Medicine, University of Pennsylvania
- Responsible party
- Principal investigator, Karina Davidson, Columbia University
- Investigators
- Karina W Davidson, PhD, Principal investigator, Columbia UniversityJ Thomas Bigger, MD, Principal investigator, Columbia UniversityRobert Carney, PhD, Principal investigator, Washington University School of MedicineKenneth Freedland, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032018
- Sponsor's protocol ID
- AAAE1932
- Other IDs
- RC2HL101663
- Acronym
- CODIACS
- Status last verified
- Aug 2017
- First submitted
- 11 Dec 2009
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S, Dornelas E, Duer-Hefele J, Frasure-Smith N, Freedland KE, Haas DC, Jaffe AS, Ladapo JA, Lesperance F, Medina V, Newman JD, Osorio GA, Parsons F, Schwartz JE, Shaffer JA, Shapiro PA, Sheps DS, Vaccarino V, Whang W, Ye S. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med. 2013 Jun 10;173(11):997-1004. doi: 10.1001/jamainternmed.2013.915.
PubMed 23471421
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
- ClinicalTrials.gov ID
- NCT01032018
- Acronym / sponsor ID
- CODIACS / AAAE1932
- Conditions
- Acute Coronary Syndrome, Depression
- Keywords
- Acute coronary syndrome, Depression, Satisfaction with care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, Emory University, Yale University, Washington University School of Medicine, University of Pennsylvania
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.
The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referred Care | Active comparator | Other: Standard careImmediately after the initial post-ACS screening, the participant's physician will be notified in writing if the participant is depressed according to the BDI. Depending upon the physician's own evaluation of the participant, he or she may elect to defer depression treatment, initiate it, or to refer the patient to a mental health specialist. |
| Stepped Care | Experimental | Behavioral: Problem Solving Therapy, Drug: Sertraline, citalopram, or bupropionStepped Care participants will be given a description of the choices available in this arm, including choosing antidepressant medication and/or telephone-based, Problem-Solving Therapy (PST). If the patient is randomized to Stepped Care, their physician will be informed that depression treatment is being provided by the trial. Patients will select their preferred treatment approach. Depression symptoms will be monitored to determine whether the patient is improving relative to his/her baseline score. Relapse monitoring and maintenance therapy will continue for the duration of the study. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized for ACS defined as unstable angina or MI
- BDI greater or equal to 10 and < 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion
- Age at least 35 years
- Fluent in English or Spanish
- Able to complete baseline assessment within 2-6 months of index ACS event
Key exclusion criteria (9 listed)
- Presence of non-cardiac condition likely to terminate fatally within 1 year
- Inaccessibility for intervention or follow-up (e.g., plans to move from the area)
- Cognitive impairment
- Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours)
- Suicidal ideation
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 |
|---|---|---|
| Problem Solving TherapyProblem Solving Therapy (PST) will be administered by a trained provider. The concepts of PST will be taught to the participant in the first session and reinforced across subsequent sessions. Sessions will last between 30 and 60 minutes each and continue weekly for the duration of the study (6 months). | Behavioural | Stepped Care |
| Sertraline, citalopram, or bupropionAntidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week,with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST-PC after 2-4 weeks and 'restart' step 1. Sertraline: 25-150qam Citalopram: 10-40qam Bupropion: 100-450qam | Drug | Stepped Care |
| Standard careParticipants will receive standard of care from the current physicians | Other | Referred Care |
Primary outcome
Depressive Symptom Reduction
Time frame: Change from depression at baseline to depression at 6-months
Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.
Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23471421Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S, Dornelas E, Duer-Hefele J, Frasure-Smith N, Freedland KE, Haas DC, Jaffe AS, Ladapo JA, Lesperance F, Medina V, Newman JD, Osorio GA, Parsons F, Schwartz JE, Shaffer JA, Shapiro PA, Sheps DS, Vaccarino V, Whang W, Ye S. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med. 2013 Jun 10;173(11):997-1004. doi: 10.1001/jamainternmed.2013.915.
- Related InfoLink provided by the sponsor.
- Baseline design paperLink provided by the sponsor.
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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
J Thomas Bigger, MD principal investigator
Columbia University
Robert Carney, PhD principal investigator
Washington University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Problem Solving Therapy and Sertraline, citalopram, or bupropion in people with Acute Coronary Syndrome and Depression, run by Columbia University at 5 sites 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 6 inclusion and 9 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Aug 2014). 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?
Depressive Symptom Reduction (time frame: Change from depression at baseline to depression at 6-months). 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?
On the ClinicalTrials.gov record for NCT01032018, which also lists 1 linked publication.
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 13 Sep 2017.