Trial Outcomes & Findings for An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder (NCT NCT01587118)

Last Updated: 2019-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

baseline, week 4, 8, and 12

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	2
Overall Study Relocation	1
Overall Study nonresponse	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antidepressant Plus Asenapine n=18 Participants 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.
Age, Continuous	48.3 years STANDARD_DEVIATION 11.9 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	11 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants

PRIMARY outcome

Timeframe: baseline, week 4, 8, and 12

Population: 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

Outcome measures

Outcome measures
Measure	Antidepressant Plus Asenapine n=18 Participants 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.
Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total	-39 units on a scale Standard Deviation 18.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Antidepressant Plus Asenapine n=18 Participants 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.
Change From Baseline in Brief Psychiatric Rating Scale (BPRS)	-15.5 units on a scale Standard Deviation 9.3

Adverse Events

Antidepressant Plus Asenapine

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antidepressant Plus Asenapine n=18 participants at risk 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.
Psychiatric disorders Psychiatric hospitalization	5.6% 1/18 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Antidepressant Plus Asenapine n=18 participants at risk 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.
Nervous system disorders sedation with syncope	5.6% 1/18 • Number of events 1 • 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.
Metabolism and nutrition disorders weight gain	5.6% 1/18 • Number of events 1 • 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.
Nervous system disorders sedation	11.1% 2/18 • Number of events 2 • 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.
Nervous system disorders extrapyramidal side effect	5.6% 1/18 • Number of events 1 • 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.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • 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.
Infections and infestations sinus infection	5.6% 1/18 • Number of events 1 • 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.
Gastrointestinal disorders upset stomach	5.6% 1/18 • Number of events 1 • 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.
General disorders fatigue	5.6% 1/18 • Number of events 1 • 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.
General disorders agitation	5.6% 1/18 • Number of events 1 • 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.

Additional Information

Sandra Creel

Tuscaloosa Research and Education Advancement Corp

Phone: 205-554-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place