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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
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Forest Laboratories
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation

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
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antidepressant Plus Asenapine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 18 [1]
Completed 11
Not Completed 7
Reason Not Completed
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.
Arm/Group Title Antidepressant Plus Asenapine
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
48.3  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  61.1%
White
6
  33.3%
More than one race
1
   5.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total
Hide Description 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.
Time Frame baseline, week 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively
Arm/Group Title Antidepressant Plus Asenapine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-39  (18.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant Plus Asenapine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments The a priori threshold for statistical significance was p</= 0.05
Method ANOVA
Comments Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.
2.Secondary Outcome
Title Change From Baseline in Brief Psychiatric Rating Scale (BPRS)
Hide Description 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.
Time Frame Baseline, week 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively
Arm/Group Title Antidepressant Plus Asenapine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.5  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant Plus Asenapine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0006
Comments The a priori threshold for statistical significance was p</= 0.05
Method ANOVA
Comments Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.
Time Frame Adverse events were collected for the 12 weeks of active study participation; Serious adverse events were collected for the 12 weeks of study and one additional post-study month.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antidepressant Plus Asenapine
Hide Arm/Group Description

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.

All-Cause Mortality
Antidepressant Plus Asenapine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Antidepressant Plus Asenapine
Affected / at Risk (%) # Events
Total   1/18 (5.56%)    
Psychiatric disorders   
Psychiatric hospitalization  1 [1]  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
One participant was hospitalized on psychiatric unit in the month following study exit while not on asenapine; Unrelated SAE.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Antidepressant Plus Asenapine
Affected / at Risk (%) # Events
Total   6/18 (33.33%)    
Gastrointestinal disorders   
upset stomach  1 [1]  1/18 (5.56%)  1
General disorders   
fatigue  1 [2]  1/18 (5.56%)  1
agitation  1 [3]  1/18 (5.56%)  1
Infections and infestations   
sinus infection  1 [4]  1/18 (5.56%)  1
Metabolism and nutrition disorders   
weight gain  1 [5]  1/18 (5.56%)  1
Nervous system disorders   
sedation with syncope  1 [6]  1/18 (5.56%)  1
sedation  1 [7]  2/18 (11.11%)  2
extrapyramidal side effect  1 [8]  1/18 (5.56%)  1
Headache  1 [9]  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
asenapine 10mg/d
[2]
10mg/d asenapine
[3]
day 4 on 5mg/d asenapine, stopped asenapine
[4]
Unrelated to asenapine
[5]
weight gain at week 4 on 5mg/d asenapine; stopped asenapine
[6]
sedation with syncope day 1 while on asenapine 5mg/d; stopped study medication.
[7]
sedation at week 4 in one participant and sedation at week 12 in one participant; both stopped asenapine.
[8]
extrapyramidal side effects at week 12 on 20mg/d asenapine; stopped asenapine
[9]
On 10mg/d asenapine

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.

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
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