An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Adjunctive asenapine
Intervention description: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.
Intervention MeSH terms: Asenapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PTSD; Posttraumatic Stress Disorder; Asenapine; Adjunctive; antidepressant; neuroleptic

Summary:

      This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic
      Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of
      standard antidepressant treatment.
    

Eligibility criteria:

        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 < 75,000/mm; hemoglobin <9g/dL; neutrophils,
             absolute < 1000/mm; LFTs > 3x upper limit; creatinine > 2 mg/dL; diastolic BP < 60 or
             > 110mmHg; EKG QTc > 475 msec.

          -  In regard to vulnerable patient populations, persons with dementia, minors (<age 19),
             the elderly (>age 65), prisoners and the terminally ill are excluded.