Anxiety DisorderPhase 3NCT00114374
SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and PTSD in Physical Trauma Victims
A Phase 3 study testing Escitalopram in people with Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Escitalopram
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2007
- Phase
- Phase 3
- 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
- Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) symptoms of Acute Stress Disorder as defined by DSM-IV criteria: A1, A2 and at least one additional category of Acute Stress Disorder symptoms (i.e., B, C and or D criteria).
- Patients must have had a medical trauma (even if fully resolved or minor) within the prior 3 weeks resulting in admission to the emergency room and/or inpatient hospital as part of their acute trauma resulting in ASD symptoms.
Who cannot join
- Patients will be excluded from entry into the study for current serious medical instability such as hemodynamic compromise, or serious head injury resulting in impaired mental status. Patients with a history of medical instability associated with their traumatic injury will be allowed study entry once the problem has resolved (as long as resolves within 3 weeks of trauma as per inclusion criteria).
- Patients with a trauma resulting in head injury related seizures, or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
- Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
- Concurrent use of other antidepressants, with the exception of trazodone < 100mg/day for sleep, or amitriptyline in doses ≤ 50 mg daily for pain. Patients may remain on concomitant benzodiazepines (<2 mg/d clonazepam or its equivalent), or sleep aids (i.e., trazodone, zolpidem (Ambien), zaleplon (Sonata)) as long as the drug therapy was initiated at 1 week prior to randomization; the dose will be held constant through the study, and will be controlled for in the analysis.
- Lifetime diagnosis of schizophrenia or any other psychosis, mental retardation, organic mental disorders, bipolar disorder; obsessive-compulsive disorder, eating disorders, cutting or other significant self-injurious behavior, or alcohol/substance abuse disorders within the last 3 months are study exclusions. Patients with a current primary diagnosis of major depression, dysthymia, social anxiety disorder, panic disorder, and generalized anxiety disorder are excluded; thus, the presence of these disorders is permissible as long as the ASD symptoms constitute the predominant symptomatology.
- Patients with a history of hypersensitivity or prior poor response to escitalopram are excluded.
- Concurrent dynamic or supportive psychotherapy is permitted as long as it has been ongoing for at least 1 month prior to onset of study entry.
- Patients with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and Posttraumatic Stress Disorder in Physical Trauma Victims in the Medical Setting
The purpose of this study is to examine the efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD symptoms.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a relatively common, distressing and disabling condition that may occur after trauma related events including injury. The emergence of Acute Stress Disorder shortly after the trauma appears to be a strong predictor of who will later develop PTSD (Brewin et al., 1999). Although SSRIs are commonly administered in general medical practice and have been demonstrated effective for the treatment of PTSD, there has not been systematic study of their use for the treatment of ASD, ASD symptoms, or the prevention of PTSD, and this study represents one of the first attempts to systematically evaluate their use for this indication.
Sixty study participants (for 30 randomized) will be drawn from patients admitted to the Massachusetts General Hospital medical/surgical inpatient units for a traumatic injury that occurred in the prior 3 weeks. Study participants must meet criteria for the A1, A2 and at least one additional category of Acute Stress Disorder symptoms (i.e., B, C and or D criteria), as determined by the Acute Stress Disorder Interview upon initial evaluation, to qualify for randomization in a 12 week, double-blind flexible-dose treatment trial of escitalopram (10-40 mg/d) versus placebo.
- Conditions
- Anxiety Disorder
- Being tested
- Escitalopram
- Keywords
- Acute Stress Disorder, Posttraumatic Stress Disorder, Escitalopram, Double-Blind
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of Acute Stress Disorder
Symptoms of Posttraumatic Stress Disorder
Secondary outcomes (1)
Clinical Global Improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2005 (estimated)
- Study startJun 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi M. Simon, Massachusetts General Hospital
- Investigators
- Naomi M Simon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114374
- Sponsor's protocol ID
- 2004-P-001633
- Status last verified
- Jun 2014
- First submitted
- 14 Jun 2005
- Last updated
- 9 Jun 2014
- Results posted
- No
Publications
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and Posttraumatic Stress Disorder in Physical Trauma Victims in the Medical Setting
- ClinicalTrials.gov ID
- NCT00114374
- Acronym / sponsor ID
- 2004-P-001633
- Conditions
- Anxiety Disorder
- Keywords
- Acute Stress Disorder, Posttraumatic Stress Disorder, Escitalopram, Double-Blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Jun 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 efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD symptoms.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a relatively common, distressing and disabling condition that may occur after trauma related events including injury. The emergence of Acute Stress Disorder shortly after the trauma appears to be a strong predictor of who will later develop PTSD (Brewin et al., 1999). Although SSRIs are commonly administered in general medical practice and have been demonstrated effective for the treatment of PTSD, there has not been systematic study of their use for the treatment of ASD, ASD symptoms, or the prevention of PTSD, and this study represents one of the first attempts to systematically evaluate their use for this indication.
Sixty study participants (for 30 randomized) will be drawn from patients admitted to the Massachusetts General Hospital medical/surgical inpatient units for a traumatic injury that occurred in the prior 3 weeks. Study participants must meet criteria for the A1, A2 and at least one additional category of Acute Stress Disorder symptoms (i.e., B, C and or D criteria), as determined by the Acute Stress Disorder Interview upon initial evaluation, to qualify for randomization in a 12 week, double-blind flexible-dose treatment trial of escitalopram (10-40 mg/d) versus placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) symptoms of Acute Stress Disorder as defined by DSM-IV criteria: A1, A2 and at least one additional category of Acute Stress Disorder symptoms (i.e., B, C and or D criteria).
- Patients must have had a medical trauma (even if fully resolved or minor) within the prior 3 weeks resulting in admission to the emergency room and/or inpatient hospital as part of their acute trauma resulting in ASD symptoms.
Key exclusion criteria (8 listed)
- Patients will be excluded from entry into the study for current serious medical instability such as hemodynamic compromise, or serious head injury resulting in impaired mental status. Patients with a history of medical instability associated with their traumatic injury will be allowed study entry once the problem has resolved (as long as resolves within 3 weeks of trauma as per inclusion criteria).
- Patients with a trauma resulting in head injury related seizures, or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
- Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
- Concurrent use of other antidepressants, with the exception of trazodone < 100mg/day for sleep, or amitriptyline in doses ≤ 50 mg daily for pain. Patients may remain on concomitant benzodiazepines (<2 mg/d clonazepam or its equivalent), or sleep aids (i.e., trazodone, zolpidem (Ambien), zaleplon (Sonata)) as long as the drug therapy was initiated at 1 week prior to randomization; the dose will be held constant through the study, and will be controlled for in the analysis.
- Lifetime diagnosis of schizophrenia or any other psychosis, mental retardation, organic mental disorders, bipolar disorder; obsessive-compulsive disorder, eating disorders, cutting or other significant self-injurious behavior, or alcohol/substance abuse disorders within the last 3 months are study exclusions. Patients with a current primary diagnosis of major depression, dysthymia, social anxiety disorder, panic disorder, and generalized anxiety disorder are excluded; thus, the presence of these disorders is permissible as long as the ASD symptoms constitute the predominant symptomatology.
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Symptoms of Acute Stress Disorder
Symptoms of Posttraumatic Stress Disorder
1 secondary outcome
Clinical Global Improvement
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Official Website for the Center for Anxiety and Traumatic Stress DisordersLink 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.
Naomi M Simon, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram in people with Anxiety Disorder, run by Massachusetts General Hospital 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 2 inclusion and 8 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 9 Jun 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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. 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?
Symptoms of Acute Stress Disorder. 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 NCT00114374, 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 9 Jun 2014.