Acute Coronary SyndromePhase 1/2NCT01667744
Citalopram for Sx/Util in Acute Coronary Syndrome Patients
A Phase 1/2 study testing Citalopram in people with Acute Coronary Syndrome, run by Henry Ford Health System at 1 site in United States.
Trial summary
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 16 Feb 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins
Who cannot join
- age less than 18
- cognitive impairment (per MMSE)
- geographic unavailability for followup
- unwillingness to participate
- illiteracy
- Hx cardiac transplant
Show all 16Show fewer
- untreated hypothyroidism
- hepatic dysfunction
- prior adverse reaction to citalopram
- history of Bipolar Disorder
- untreated Sleep Apnea
- chronic steroid therapy
- active substance abuse (e.g., within past year)
- near term mortal illness
- current mental health treatment
- signitificant suicide risk
Trial locations and contacts
1 site in 1 country.
About this study
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.
This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.
Read the detailed description
Not applicable. Study not funded.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Citalopram
- Keywords
- Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization
- Medical subject headings
- Acute Coronary Syndrome, Angina Pectoris, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pill Receives: Drug: Citalopram |
| Citalopram | Experimental | Drug Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ACS Symptoms
Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
Measured: 6 months
Treatment usage
ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
Measured: 6 months
Secondary outcomes (1)
Emotional Distress
Depression per PHQ9, Anxiety per GAD7 \& Anxiety/Depression/AIAI per KSSFC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study start1 Jan 2016 (estimated)
- Primary completion1 Feb 2016 (estimated)
- Study completion16 Feb 2021
Why it stopped: unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark W. Ketterer, PhD, Henry Ford Health System
- Investigators
- Mark W Ketterer, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667744
- Sponsor's protocol ID
- 11146121
- Status last verified
- Dec 2022
- First submitted
- 12 Aug 2012
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Study not funded.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citalopram for Sx/Util in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT01667744
- Acronym / sponsor ID
- 11146121
- Conditions
- Acute Coronary Syndrome
- Keywords
- Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2016 (estimated)
- Primary completion
- 1 Feb 2016 (estimated)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 17 Aug 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.
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.
This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.
Detailed description
Not applicable. Study not funded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: CitalopramPlacebo pill |
| Citalopram | Experimental | Drug: CitalopramDrug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins
Key exclusion criteria (16 listed)
- age less than 18
- cognitive impairment (per MMSE)
- geographic unavailability for followup
- unwillingness to participate
- illiteracy
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 |
|---|---|---|
| Citalopram10 mg/day | Drug | Citalopram, Placebo |
Primary outcome
Frequency of ACS Symptoms
Time frame: 6 months
Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
Treatment usage
Time frame: 6 months
ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
1 secondary outcome
Emotional Distress
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: Undecided. Study not funded.
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AI-Assisted Interpretation of Cardiac CT in the Emergency Department
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Enrolling by invitation
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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.
Mark W Ketterer, PhD principal investigator
Henry Ford Health System
1 site 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 Citalopram in people with Acute Coronary Syndrome, run by Henry Ford Health System 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 1 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Dec 2022. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of ACS Symptoms (time frame: 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?
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 9 Dec 2022.