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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587118
First Posted: April 27, 2012
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Forest Laboratories
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
April 25, 2012
April 27, 2012
July 18, 2016
December 5, 2016
December 5, 2016
June 2012
July 2016   (Final data collection date for primary outcome measure)
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.
Reduction in Clinical Administered PTSD Scale (CAPS)Score [ Time Frame: baseline, 4, 8, and 12 weeks ]
Asenapine-treated subjects with PTSD will have significantly reduced PTSD symptoms (Clinician Administered PTSD Scale [CAPS] total and Davidson Trauma Scale).
Complete list of historical versions of study NCT01587118 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
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
Experimental: antidepressant plus asenapine
adjunctive asenapine
Intervention: Drug: Adjunctive asenapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2016
July 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01587118
00156
No
Not Provided
Plan to Share IPD: No
Plan Description: No sharing of individual participant data
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
Lori Davis, MD
  • Merck Sharp & Dohme Corp.
  • Forest Laboratories
Principal Investigator: Lori L Davis, MD Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa Research & Education Advancement Corporation
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP