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

NCT01587118 | Completed Phase 4 Results

• 1 other identifier: 00156
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Posttraumatic Stress Disorder

Keywords

PTSD; Posttraumatic Stress Disorder; Asenapine; Adjunctive; antidepressant; neuroleptic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total

  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.

  baseline, week 4, 8, and 12

Secondary Outcomes (1)

• Change From Baseline in Brief Psychiatric Rating Scale (BPRS)

  Baseline, week 4, 8, 12

Study Arms (1)

antidepressant plus asenapine

EXPERIMENTAL

adjunctive asenapine

Drug: Adjunctive asenapine

Interventions

Adjunctive asenapine DRUG

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.

Also known as: asenapine, Saphris

antidepressant plus asenapine

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent and acceptable proof of identity.
• Male or female subjects ≥19 to 65 years of age of any race or ethnic origin.
• Not currently pregnant, breastfeeding or planning on becoming pregnant; use of contraception as follows:
• Males - those that are sexually active must use a double barrier method of contraception (condom with spermicide) from the first dose of asenapine until 12 weeks after last dose of asenapine
• Women of child-bearing potential - must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control for 3 months before enrollment and until 12 weeks after their last dose of asenapine.
• Women of non-child bearing potential - women who are either permanently sterilized (hysterectomy, bilateral oophorectomy and bilateral salpingectomy but excluding bilateral tubal occlusion) or who are postmenopausal.
• Diagnosis of PTSD (DSM-IV-TR criteria; confirmed by MINI and CAPS).
• Total CAPS score \> 45.
• Currently taking an approved antidepressant at acceptable dose for 8 weeks or more with non-remission of symptoms.
• No substance use disorders of dependence (except for nicotine, caffeine) in previous 4 wks.
• No substance use disorders of abuse (except for nicotine and caffeine) in the previous 2 wks.
• Physical and laboratory panel (within past one year) are within normal limits or not clinically significant

You may not qualify if:

• Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by the MINI)
• Actively considering plans of suicide or homicide (assessed by clinical interview)
• Psychotic symptoms that in the investigator's opinion impair the subject's ability to give informed consent
• A contraindication to the use of asenapine or antidepessant
• Intolerable side effects or allergic reaction to asenapine or the current antidepressant
• Women planning to become pregnant or breastfeed during the study
• In regard to vulnerable patient populations, persons with dementia, minors (\<age 19), the elderly (\>age 65), prisoners and the terminally ill are excluded.

Sponsors & Collaborators

• Lori Davis, MD: lead
• Merck Sharp & Dohme LLC: collaborator
• Forest Laboratories: collaborator

Study Sites (1)

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

• Pilkinton P, Berry C, Norrholm S, Bartolucci A, Birur B, Davis LL. An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder. Psychopharmacol Bull. 2016 Aug 15;46(2):8-17. doi: 10.64719/pb.4349.

  PMID: 27738377 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

asenapine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Sandra Creel
• Organization: Tuscaloosa Research and Education Advancement Corp

sandra.creel@va.gov

205-554-2000

Study Officials

• Lori L Davis, MD

  Tuscaloosa Research & Education Advancement Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief of Staff, Research and Development Service

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 11, 2019
• Results First Posted: December 5, 2016

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)