At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 18 enrolled
Drug / intervention
Adjunctive asenapinedrug
Likely dose
Adjunctive asenapine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
In Brief
A Phase 4 clinical trial evaluating Adjunctive asenapine for Posttraumatic Stress Disorder. Completed, enrolled 18 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPosttraumatic Stress Disorder
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Forest Laboratories
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartJun 2012
Primary CompletionJul 2016
TodayJul 2026
First PostedApr 27, 2012
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.2 years ago
Interventions
Adjunctive asenapinedrug
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.