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

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ClinicalTrials.gov Identifier: NCT01587118
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Adjunctive asenapine Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Study Start Date : June 2012
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: antidepressant plus asenapine
adjunctive asenapine
Drug: Adjunctive asenapine
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.
Other Names:
  • asenapine
  • Saphris

Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total [ Time Frame: baseline, week 4, 8, and 12 ]
    CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.

Secondary Outcome Measures :
  1. Change From Baseline in Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, week 4, 8, 12 ]
    BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587118

United States, Alabama
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Lori Davis, MD
Merck Sharp & Dohme Corp.
Forest Laboratories
Principal Investigator: Lori L Davis, MD Tuscaloosa Research & Education Advancement Corporation
More Information

Responsible Party: Lori Davis, MD, Associate Chief of Staff, Research and Development Service, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT01587118     History of Changes
Other Study ID Numbers: 00156
First Posted: April 27, 2012    Key Record Dates
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing of individual participant data

Keywords provided by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation:
Posttraumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs