DepressionPhase 4ANDROSNCT02463110
Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin
A Phase 4 study testing Sertraline and No treatment in people with Depression and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary purpose: To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI) compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as recommended by a double antiplatelet therapy, aspirin and clopidogrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Coronary Artery Disease
- What is being tested?
- Sertraline and No treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Aged 18 years and older
- Patient Depressive without antidepressant therapy for three months (valid only for the sertraline and placebo groups)
- Patient With ACS with elevated cardiac enzymes (above the 99th percentile of the upper limit of normal of the laboratory)
- Patient That assessed depressive symptoms : Test Beck (13 items)
- Patient Affiliated to a social security scheme (beneficiary or assignee)
- Patient Having signed a free and informed consent
Who cannot join
- Cardiovascular
- History of serious bleeding (recent hemoglobin fall 5g / dl ( <3 months ), intracranial hemorrhage or hemorrhagic tamponade)
- Uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg)
- Stroke <3 months
- Treatment with ticagrelor or prasugrel for the duration of the study.
- Psychiatric
Show all 26Show fewer
- Psychosis, bipolar illness
- Dementia (Mini- Mental State Examination score < 23)
- Uncontrolled epilepsy
- Severe depression (score > 15) with suicidal risk identified by a psychiatrist (urgent treatment for depression needed)
- Patient experienced depression and treated in the last three months or currently receiving treatment
- Treatment with selective and non-selective monoamine oxidase inhibitors of the group A within 14 days prior to the introduction of sertraline
- Clinical and Biological
- Prothrombin time > 1.5 second
- Platelet rate < 100 000 / mm3
- Hematocrit rate < 25%
- Serum creatinine > 4.0 mg / dl
- Severe hepatic impairment (Child Pugh stage C)
- Contraindications to sertraline (placebo / sertraline group)
- Hypersensitivity to the active substance or to any of the excipients (anhydrous lactose, pregelatinized corn starch, sodium laurilsulfate , magnesium stearate)
- Treatment with pimozide
- Genetic galactose intolerance, malabsorption of glucose and galactose, lactase deficiency
- Regulatory
- Women without effective contraception or pregnant or lactating or desiring pregnancy or within 6 months after randomization
- Participation in biomedical research on other drugs during the period of participation
- Patients unable to follow the treatment
Trial locations and contacts
1 site in 1 country.
France1 site
ACTION Group - Pitié-Salpêtrière University Hospital (APHP)
Paris, 75013
About this study
Official title: Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin: The ANDROS Study
Primary purpose:
To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI) compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as recommended by a double antiplatelet therapy, aspirin and clopidogrel.
Hypothesis:
The benefits of SSRIs observed in depressive patients with ACS are related to an antiplatelet effect.
Read the detailed description
Rational:
40% of patients hospitalized for acute coronary syndrome (ACS) present depressive symptoms. The increase in cardiovascular morbidity and mortality at 6 months (hazard ratio = 3.5) could partly be explained by an alteration of the platelet parameters in patients with depression.
Sertraline is a potent inhibitor of the selective serotonin reuptake (SSRI). At the platelet level, it decreases the secretion induced by collagen and causes the inhibition of serotonin reuptake and platelet activation, wider than the simple anti-serotonergic effect. Its efficacy on depression of patients with ACS has been demonstrated (-20% of ischemic events at 24 weeks vs placebo), partly independent of the correction of depressive symptoms, and with a wide safety action. Antiplatelet, anti-inflammatory and endothelial function effects of sertraline are demonstrated in healthy volunteers, in stable patients and in patients with heart failure, but have never been explored in ACS .
Multicenter, randomized, double-blind, controlled trial comparing SSRI and placebo in depressive patients with ACS.
A control (non depressive) ACS group will also do the clinical and laboratory follow-up at the same time (without drug administration), to constitute a reference for platelet parameters and to allow a comparison with the depressive ACS group treated with placebo.
Randomization and initiation of the treatment at the end of the hospitalization for ACS (possibly after reperfusion and stabilization of cardiac medication)
- Conditions
- Depression, Coronary Artery Disease
- Being tested
- Sertraline, No treatment, Placebo
- Keywords
- Acute Coronary Syndrome, Depression, Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention
- Medical subject headings
- Depression, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Sertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months.
No treatmentDrug
PlaceboDrug
Also called Placebo one capsule, which can be increased up to 4 capsules per day (maximum dose) for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1: Sertraline | Experimental | ACS, depression Receives: Drug: Sertraline |
| 2: Placebo | Placebo comparator | ACS, depression Receives: Drug: Placebo |
| 3: Control | Other | ACS, no depression, no treatment Receives: Drug: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time dependent pattern of changes in platelet reactivity under sertraline compared to placebo within a time Frame of 6 months of treatment
To evaluate the time variation of the level of platelet reactivity (ADP induced residual aggregation) under sertraline compared to placebo within a time Frame of 6 months of treatment.
Time Frame:
T0 = before starting treatment with sertraline T1 = at discharge from the hospital = J1 after introduction of treatment with sertraline T2 = 6 weeks of treatment with sertraline T3 = 24 weeks of treatment with sertraline = end of treatment with sertraline T4 = 4 weeks after the end of treatment with sertraline (biological and psychiatric rebound)
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Secondary outcomes (5)
Time dependent pattern of changes in platelet activation
Maximal platelet aggregation (ADP, Arachidonic Acid, Collagen), markers of platelet activation (betaTG, CD40s)
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent pattern of changes in inflammation markers
Dosage of inflammation markers (IL-6, CRP, Fg, myeloperoxydase)
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Depression
Beck Depression Inventory (BDI)
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Tobacco addiction
Fargenström test
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Bleeding risk
Dosage of hemoglobin, hematocrit and follow-up of hemorrhage
Measured: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Investigator's decision
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Action Research Group
- Responsible party
- Sponsor
- Investigators
- Johanne SILVAIN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463110
- Sponsor's protocol ID
- P110155
- Acronym
- ANDROS
- Status last verified
- May 2016
- First submitted
- 19 May 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin: The ANDROS Study
- ClinicalTrials.gov ID
- NCT02463110
- Acronym / sponsor ID
- ANDROS / P110155
- Conditions
- Depression, Coronary Artery Disease
- Keywords
- Acute Coronary Syndrome, Depression, Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator's decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Action Research Group
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Jun 2015 (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.
Primary purpose:
To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI) compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as recommended by a double antiplatelet therapy, aspirin and clopidogrel.
Hypothesis:
The benefits of SSRIs observed in depressive patients with ACS are related to an antiplatelet effect.
Detailed description
Rational:
40% of patients hospitalized for acute coronary syndrome (ACS) present depressive symptoms. The increase in cardiovascular morbidity and mortality at 6 months (hazard ratio = 3.5) could partly be explained by an alteration of the platelet parameters in patients with depression.
Sertraline is a potent inhibitor of the selective serotonin reuptake (SSRI). At the platelet level, it decreases the secretion induced by collagen and causes the inhibition of serotonin reuptake and platelet activation, wider than the simple anti-serotonergic effect. Its efficacy on depression of patients with ACS has been demonstrated (-20% of ischemic events at 24 weeks vs placebo), partly independent of the correction of depressive symptoms, and with a wide safety action. Antiplatelet, anti-inflammatory and endothelial function effects of sertraline are demonstrated in healthy volunteers, in stable patients and in patients with heart failure, but have never been explored in ACS .
Multicenter, randomized, double-blind, controlled trial comparing SSRI and placebo in depressive patients with ACS.
A control (non depressive) ACS group will also do the clinical and laboratory follow-up at the same time (without drug administration), to constitute a reference for platelet parameters and to allow a comparison with the depressive ACS group treated with placebo.
Randomization and initiation of the treatment at the end of the hospitalization for ACS (possibly after reperfusion and stabilization of cardiac medication)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Sertraline | Experimental | Drug: SertralineACS, depression |
| 2: Placebo | Placebo comparator | Drug: PlaceboACS, depression |
| 3: Control | Other | Drug: No treatmentACS, no depression, no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient Aged 18 years and older
- Patient Depressive without antidepressant therapy for three months (valid only for the sertraline and placebo groups)
- Patient With ACS with elevated cardiac enzymes (above the 99th percentile of the upper limit of normal of the laboratory)
- Patient That assessed depressive symptoms : Test Beck (13 items)
- Patient Affiliated to a social security scheme (beneficiary or assignee)
Key exclusion criteria (26 listed)
- Cardiovascular
- Psychiatric
- Clinical and Biological
- Contraindications to sertraline (placebo / sertraline group)
- Regulatory
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 |
|---|---|---|
| SertralineSertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months. | Drug | 1: Sertraline |
| No treatment | Drug | 3: Control |
| PlaceboAlso: Placebo one capsule, which can be increased up to 4 capsules per day (maximum dose) for 6 months. | Drug | 2: Placebo |
Primary outcome
Time dependent pattern of changes in platelet reactivity under sertraline compared to placebo within a time Frame of 6 months of treatment
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
To evaluate the time variation of the level of platelet reactivity (ADP induced residual aggregation) under sertraline compared to placebo within a time Frame of 6 months of treatment. Time Frame: T0 = before starting treatment with sertraline T1 = at discharge from the hospital = J1 after introduction of treatment with sertraline T2 = 6 weeks of treatment with sertraline T3 = 24 weeks of treatment with sertraline = end of treatment with sertraline T4 = 4 weeks after the end of treatment with sertraline (biological and psychiatric rebound)
5 secondary outcomes
Time dependent pattern of changes in platelet activation
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent pattern of changes in inflammation markers
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Depression
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Tobacco addiction
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Bleeding risk
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Results and safety
The study was stopped early (reason given: Investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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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.
Johanne SILVAIN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 No treatment in people with Depression and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 26 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 3 May 2016. 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 France. 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?
The study was stopped early (reason given: Investigator's decision). 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?
Time dependent pattern of changes in platelet reactivity under sertraline compared to placebo within a time Frame of 6 months of treatment (time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 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 3 May 2016.