An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder

Inclusion Criteria

• Signed and dated informed consent and acceptable proof of identity.
• Male or female subjects ≥19 to 65 years of age of any race or ethnic origin.
• Not currently pregnant, breastfeeding or planning on becoming pregnant; use of contraception as follows:
• Males - those that are sexually active must use a double barrier method of contraception (condom with spermicide) from the first dose of asenapine until 12 weeks after last dose of asenapine
• Women of child-bearing potential - must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control for 3 months before enrollment and until 12 weeks after their last dose of asenapine.
• Women of non-child bearing potential - women who are either permanently sterilized (hysterectomy, bilateral oophorectomy and bilateral salpingectomy but excluding bilateral tubal occlusion) or who are postmenopausal.
• Diagnosis of PTSD (DSM-IV-TR criteria; confirmed by MINI and CAPS).
• Total CAPS score > 45.
• Currently taking an approved antidepressant at acceptable dose for 8 weeks or more with non-remission of symptoms.
• No substance use disorders of dependence (except for nicotine, caffeine) in previous 4 wks.
• No substance use disorders of abuse (except for nicotine and caffeine) in the previous 2 wks.
• Physical and laboratory panel (within past one year) are within normal limits or not clinically significant

Exclusion Criteria

• Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by the MINI)
• Actively considering plans of suicide or homicide (assessed by clinical interview)
• Psychotic symptoms that in the investigator's opinion impair the subject's ability to give informed consent
• A contraindication to the use of asenapine or antidepessant
• Intolerable side effects or allergic reaction to asenapine or the current antidepressant
• Women planning to become pregnant or breastfeed during the study
• Clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event, including but not limited to: unstable or severe hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease; hypo- or hyperthyroidism, unless the condition has been stabilized; or a history of seizures (except for a single childhood febrile seizure, posttraumatic, or alcohol withdrawal). The following are exclusionary: platelets 3x upper limit; creatinine > 2 mg/dL; diastolic BP 110mmHg; EKG QTc > 475 msec.
• In regard to vulnerable patient populations, persons with dementia, minors ( age 65), prisoners and the terminally ill are excluded.