Clinical trial NCT01587118: An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Official title: An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Posttraumatic Stress Disorder
Asenapine
Adjunctive
antidepressant
neuroleptic
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Forest Laboratories
First posted: 2012-04-27
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.

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.

Primary outcomes:
measure: Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total
timeFrame: baseline, week 4, 8, and 12
Secondary outcomes:
measure: Change From Baseline in Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, week 4, 8, 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
Study officials:
affiliation: Tuscaloosa Research & Education Advancement Corporation
name: Lori L Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilkinton P, Berry C, Norrholm S, Bartolucci A, Birur B, Davis LL. An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder. Psychopharmacol Bull. 2016 Aug 15;46(2):8-17.