Please select the eligibility criteria that correspond to the clinical trial below.
Title: Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
Brief Summary: The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.


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:

* Third-trimester pregnant women being followed at the Massachusetts General Hospital (MGH) Obstetrics Program
* At risk of postpartum depression (PPD)

Exclusion Criteria:

* Failure to participate in regular prenatal check-ups
* Current diagnosis Diagnostic and Statistical Manual of Mental Disorders (DSM-5) mental disorder pertaining to psychosis or substance abuse
* Suicidality
* Obstetric complication (e.g., preeclampsia, excessive hemorrhaging)
* Use of potentially confounding or interacting medications
* Complicating pediatric medical condition in the newborn
C: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Patients must provide acceptable proof of identity documentation to confirm initials and date of birth
3. Male and female patients aged 21 to 65 years, inclusive.
4. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 12 weeks after their last dose. All females must have a negative serum pregnancy test. Women of childbearing potential (WOCBP, see below) must use a highly effective form of birth control plus the use of a condom by the male sexual partner, reviewed and approved by the PI. The highly effective form of birth control includes: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD/IUS, Depo-Provera injections, oral contraceptive, and Evra Patch or Nuvaring. Women should be on a stable method of birth control for a minimum of 3 months , prior to randomization and 3 months after the last dose of IP.

   Women of non-childbearing potential. Women of non-childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they are amenorrheic for 12 months prior to randomization without an alternative medical cause. The following age-specific requirements apply:

   Women \< 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.

   Women ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
5. CAPS-5 score ≥ 25 and CGI-S ≥ 4 at Screening and Randomization
6. Anxiety Potentiated Startle T-score ≥ 2.8.
7. Psychotropic medications must remain at a stable dose for at least 42 days prior to screening, without clinically significant adjustment.
8. Be able to understand and comply with the requirements of the study, as judged by the investigator

Exclusion Criteria:

1. Patients who are currently participating in another clinical study in which the patient is exposed to an investigational or non-investigational drug or device, or have done so within the last 30 days prior to screening.
2. Patients who have no regular contact with an adult who could come to the patient's aid should an urgent need arise.
3. Patients with a history of DSM-5 diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, or currently exhibiting psychotic symptoms associated with depression; dementia or suspicion thereof, is also exclusionary.
4. Currently being treated with MAOIs, lithium, divalproex, carbamazepine, barbiturates, or benzodiazepines. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[eg, riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the mu-opioid receptor.
5. Patients who meet DSM-5 criteria for substance use disorder (amphetamines, cocaine, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics) within 1 month prior to screening. Patients with a positive urine drug screen (UDS) are excluded except for patients testing positive for prescribed medications that are otherwise permitted and there is no evidence of misuse or abuse. Patients can be re-tested only if either the initial opiate or barbiturate result is positive and they have a prescription, but the patient should be excluded if the result is still positive at the second test. Patients with positive UDS for drug(s) legally available by prescription must provide evidence of prescription for the drug(s).
6. Patients with a binge-pattern of alcohol use which makes them at risk for withdrawal-related seizures. Also, significant alcohol withdrawal symptoms that require medical detoxification.
7. Patients with a suicide attempt within the last 3 months or at imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigator.
8. Patients who are pregnant or lactating.
9. Clinically significant laboratory value, physical examination, or ECG that signifies a major medical illness that is unstable or inadequately controlled, or that may put the subject at risk during the study in the judgment of the investigator. Hypothyroidism is permitted if corrected and the patient is on a stable treatment regimen for a minimum of 6 months.
10. Systolic BP \< 85 or \> 160 mmHg or diastolic BP \> 100 mmHg or heart rate \< 50 or \>105 beats per minute at Screening or Randomization. Exclusionary values may be repeated once.
11. QTcF (Fridericia-corrected) ≥ 450 msec at Screening or Randomization. Exclusionary values may be repeated once.
12. Patients with any history of seizure disorder (except for febrile seizures in childhood) or traumatic brain injury.
13. Previous exposure to lanicemine.
14. Patients with a personality disorder which in the opinion of the investigator has a major impact on the patient's current psychiatric status and would preclude safe study participation.
15. Body mass index (BMI) ≥ 40 kg/m2
D: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Answer: B