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 : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Drug: Adjunctive asenapine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: antidepressant plus 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.
- 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.
- 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.
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|
|Principal Investigator:||Lori L Davis, MD||Tuscaloosa Research & Education Advancement Corporation|