Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study of Sertraline to Prevent PTSD
Brief Summary: The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1 and 2: To assess the efficacy of sertraline to prevent the development of (Aim 1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared with placebo.

This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and families are evaluated for the presence of acute stress symptoms. Children are reassessed in a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks (the midpoint of the study). At each reassessment, information is collected on the child's compliance with the study medication, the parents' assessment of the child's functioning, and the child's self-report of posttraumatic and depressive symptomatology. The main outcome variable used in this study is the child's posttraumatic symptoms.


Options:
A: Inclusion Criteria:

* Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn
* Between the ages of 6 - 20 years
* Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion
* Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion
* Proficiency in either English or Spanish

Exclusion Criteria:

* No memory of the injury
* Current use of an anti-depressant
* Known hypersensitivity to sertraline
* Diagnosis of Bipolar Disorder
* Diagnosis of PTSD
* Mental Retardation
* Traumatic Brain Injury
* New onset or marked worsening of a seizure disorder
B: Inclusion Criteria:

* Experienced an acute psychological traumatic event
* Heart rate of 80 beats per minute (bpm) or greater
* Understands English

Exclusion Criteria:

* Traumatic event that occurred more than four hours before arrival to emergency department
* Physical injury that may affect safe participation (e.g., head injury)
* Systolic blood pressure less than 100 mm Hg
* Medical or surgical condition that poses a risk of shock
* Medical condition that may affect the safe administration of propranolol
* Previous adverse reaction to, or non-compliance with, a beta-blocker
* Current use of medication that may react badly with propranolol
* Elevated saliva alcohol level
* Presence of salivary opiates, marijuana, cocaine, or amphetamines
* Pregnant or breastfeeding
* Traumatic event reflecting ongoing victimization
* Psychiatric condition that may affect safe participation
* Unwilling or unable to commute to Boston for research visits
* Attending physician in emergency department does not advise participation
C: Inclusion Criteria:

* Female patients between the ages of 18 years and 50 years
* Victim of sexual assault/rape
* Able to understand consent procedure
* Discharged to home

Exclusion Criteria:

* Admitted to inpatient unit
* Previous diagnosis of PTSD
* Contra-indications to prazosin: orthostatic hypotension, right heart failure, use of anti-hypertensive medication, 5-phosphodiesterase inhibitors (sildenafil) or diuretic, history of syncope or severe unexplained faintness, known hypersensitivity to quinazolines
* Hemodynamically unstable
* Current use of over the counter, prescribed, or use of other drugs for insomnia
* Dependence on alcohol, opiates or other illegal drugs
* History of psychotic disorder
* Suicidal risk defined by a positive response on the 3-item assessment, standard protocol in the ED
* Current use of morphine or methadone
* Pregnant or breastfeeding
* Known hepatic dysfunction
* Cardiac or vascular history including coronary artery disease
* Narcolepsy
* History of sleep apnea
* Returning to chronic domestic abuse situation
D: Inclusion Criteria:

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility to contact patients with injury in 240 hours, and dosing in oral use
4. Physical and metal status to possible understands scope and contents in the trial and gets informed consent

Exclusion Criteria:

1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
2. Cognitive impairment: Mini Mental State Examination \< 24
3. Heavy drinker or 100IU/L ≦ γGTP in administration
4. Heavy smoker (over 40 cigarettes per day)
5. History and current suspicion in diagnosis of psychosis and bipolar I disorder
6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
10. Habit of eating fish over 4 times per week

Answer: A