MedTrace Logo

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

NCT01587118 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-06-11

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Forest Laboratories

    collaborator INDUSTRY

  • Lori Davis, MD

    lead OTHER

Principal Investigators

  • Lori L Davis, MD · Tuscaloosa Research & Education Advancement Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01587118 on ClinicalTrials.gov