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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lori Davis, MD
• Collaborators: Forest Laboratories; Merck Sharp & Dohme Corp.
• Treatments: Antidepressive Agents; Asenapine

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 (the elderly (>age 65), prisoners and the terminally ill are excluded.