Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Study the Topiramate Efficacy for Posttraumatic Disorder Treatment
Brief Summary: The study is 12-week randomized placebo controlled trial compared to topiramate to treat patients with posttraumatic stress disorder, according to DSM-IV criteria.

Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every week 25mg will be increment according to patients tolerance to side effects.

Patients will be evaluated by blind raters using Clinician-Administered PTSD Scale (CAPS), Beck Depression Inventory (BDI) , Beck Anxiety Inventory (BAI), 36-Item Short Form Health Survey (SF-36), Social Adjustment Scale (SAS).

the outcomes will be improvement on Posttraumatic Stress Disorder (PTSD), Depression, Anxiety, quality of life and social adjustment scale according to scales above.


Options:
A: Inclusion Criteria:

* Diagnosis of PTSD, confirmed by Mini-International Neuropsychiatric Interview (MINI) and CAPS
* Age 19 or older
* No substance abuse/dependence for the previous 4 weeks (except for nicotine and caffeine)
* Free of psychotropic medication for 2 weeks (except 4 weeks for fluoxetine)
* Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.
* Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, Depo-Provera, or diaphragm with spermicides)
* Signed informed consent
* Male or female, any race or ethnic origin

Exclusion Criteria:

* Lifetime history of bipolar I, psychotic, or cognitive disorders
* Actively suicidal, homicidal, or psychotic
* History of sensitivity to mirtazapine
* Unstable general medical conditions
* Score 6 on Question #10 of MADRS regarding suicidal ideation
* Women who are pregnant, planning to become pregnant or breastfeed during the study
B: Inclusion Criteria:

* Participants must satisfy DSM-IV diagnostic criteria for chronic PTSD
* Evidence of PTSD disease base upon one or more of the following:
* Mild or greater depression on the Beck Depression Inventory -II (BDI-II, score\> 12).
* May have other symptom co-morbid with PTSD (e.g., anxiety or somatic pain)
* Ability to comprehend and satisfactorily comply with protocol required and signed written informed consent prior to entering study procedure
* May be in psychotherapy if initiated at least three months prior to the screening visit. Subject must not discontinue or otherwise alter therapy during the study.
* Subject may not have taken any psychopharmacological medications within 7 days prior to Baseline visit.
* Negative urine pregnancy test at screening visit and for the duration of the study for women of childbearing potential.

Exclusion Criteria:

* Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:

  1. Delirium, Dementia, Amnestic and other Cognitive disorders
  2. Lifetime Schizophrenia and other Psychotic Disorders
  3. lifetime Bipolar I Disorder
  4. Bipolar-II Disorder with an episode of hypomania within the last year
  5. Alcohol or Substance Dependence or Abuse (excluding nicotine) in one month prior to the Screening Visit
  6. Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
* Decisional incapacity (dementia)
* Use of centrally acting medications that potentially have an effect on biological expression
* Chronic pain levels requiring use of any opiate medications
* Known exposure to chemicals of physical traumas that cause neuropsychiatric sequelae
* Past chronic PTSD
* History of 2 or more treatment failures on SSRIs given primarily for the treatment of PTSD, in adequate does at the Investigator's opinion, for at least 8 weeks
* History of intolerance or hypersensitivity to SSRI's
* History of seizures
* Significant risk of committing suicide, or are homicidal or violent and in the Investigator's opinion in significant imminent risk of hurting others
* Treated with depot-neuroleptic within 3 months or MAO inhibitors within 30 day prior to Baseline visit
* Received ECT within 3 months prior to Screening visit
* Pregnant or nursing, women of childbearing potential who are sexually active and do not use adequate contraception, or who are judged to be unreliable in their use of contraception
* Positive urine drug screen, unless proven to be prescribed for a short-term course of treatment. Drug screen must be repeated at least 7 days after the last dose of prescription medication containing narcotics
* A medical condition, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
* Requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep)
* Plans to initiate or terminate any form of psychotherapy or behavior therapy during the study
* Receiving disability payments (\> 50 % service connections or total Social Security) or who are involved in litigation for PTSD or other psychiatric illnesses.
* Unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits
C: Inclusion Criteria:

* Outpatient, male and female 18 to 60 yrs old
* PTSD diagnostic according to DSM-IV criteria
* Patients who agree to receive diagnostic after SCID I application by a trained psychiatrist
* Sexually active female patients who agree to use contraceptive
* Patients who agree to sign the IRB approved informed consent

Exclusion Criteria:

* Patients who have schizophrenic disorder, delusional, psychotic depression, schizo-affective, bipolar and dependence to psychoactive substance disorders
* Patients who have clinical disorders not compensated, which require clinical treatment as priority
* Pregnancy
* Previous renal calculosis history
* Being under antidepressant, or other psychotropic medications
* BMI under 20.
D: Inclusion Criteria:

* Being between the ages of 18-65
* Having gone through a potentially traumatic event.

Exclusion Criteria:

* Not suffering from chronic PTSD
* Systolic blood pressure \<100 mm Hg;
* Heart rate below 55 beats per minute;
* Having a medical condition that contraindicates the administration of propranolol, e.g., history of congestive heart failure, heart block, insulin-requiring diabetes, chronic bronchitis, emphysema, or asthma. With regard to asthma, because many persons who say they have had an asthma attack, especially as a child, may only have had hay fever, another allergy, or another non-asthmatic episode, a blanket exclusion criterion may be overly restrictive. Therefore, asthma attacks will only be exclusionary if they a.) occurred within the past 10 years, b.) occurred at any time in life if induced by a β-blocker, or c.) are currently being treated, regardless of the date of last occurrence. Cardiological consultation will be obtained as necessary;
* Previous adverse reaction to, or non-compliance with, a β-blocker;
* Current use of a medication that may involve potentially dangerous interactions with propranolol, including, other β-blockers, antiarrhythmics, calcium channel blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritonavir. Because the protocol does not require to take large doses of propranolol on a daily basis, the decision to exclude participants will be taken by the physician on a case-by-case basis;
* Pregnancy or breast feeding. Although propranolol can be used during pregnancy we will advise women not to participate in they are or become pregnant. Women breastfeeding will also be advised not to participate because propranolol has been found in human milk. That the quantity absorbed by the breast feeding infant is inferior to 1% of the therapeutic dose (Vidal, 2008).
* Contraindicating psychiatric condition, including current psychotic, bipolar, melancholic, or substance dependence or abuse disorder; suicidality;
* Initiation of, or change in, psychotropic medication within the previous 2 months. For participants receiving stable doses of pharmacotherapy, they and their providers will be asked not to change the regimen except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating participation;
* Current participation in any psychotherapy (other than strictly supportive). Participants will be asked not to initiate psychotherapy during the course of the proposed study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating participation;
* Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation;
* Understanding neither French nor English.

Answer: C