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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
Results First Submitted: July 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Posttraumatic Stress Disorder
Intervention: Drug: Adjunctive asenapine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antidepressant Plus Asenapine

adjunctive asenapine

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.


Participant Flow:   Overall Study
    Antidepressant Plus Asenapine
STARTED   18 [1] 
COMPLETED   11 
NOT COMPLETED   7 
Adverse Event                3 
Lost to Follow-up                2 
Relocation                1 
nonresponse                1 
[1] 31 signed consent and 18 were deemed eligible and initiated treatment with adjunctive asenapine.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Antidepressant Plus Asenapine

adjunctive asenapine

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.


Baseline Measures
   Antidepressant Plus Asenapine 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.3  (11.9) 
Gender 
[Units: Participants]
 
Female   3 
Male   15 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   11 
White   6 
More than one race   1 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures
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1.  Primary:   Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total   [ Time Frame: baseline, week 4, 8, and 12 ]

2.  Secondary:   Change From Baseline in Brief Psychiatric Rating Scale (BPRS)   [ Time Frame: Baseline, week 4, 8, 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

This study was limited by both the small number of subjects enrolled and its open-label design.

Average dose of asenapine was 13.6 ± 6.4 mg/d; at 12-weeks 15.9 ± 4.9 mg/d.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sandra Creel
Organization: Tuscaloosa Research and Education Advancement Corp
phone: 205-554-2000 ext 1-2840
e-mail: sandra.creel@va.gov



Responsible Party: Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT01587118     History of Changes
Other Study ID Numbers: 00156
First Submitted: April 25, 2012
First Posted: April 27, 2012
Results First Submitted: July 18, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016