Posttraumatic Stress DisorderPhase 4NCT01587118
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
A Phase 4 study testing Adjunctive asenapine in people with Posttraumatic Stress Disorder, run by Lori Davis, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Adjunctive asenapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
- Clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event, including but not limited to: unstable or severe hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease; hypo- or hyperthyroidism, unless the condition has been stabilized; or a history of seizures (except for a single childhood febrile seizure, posttraumatic, or alcohol withdrawal). The following are exclusionary: platelets < 75,000/mm; hemoglobin <9g/dL; neutrophils, absolute < 1000/mm; LFTs > 3x upper limit; creatinine > 2 mg/dL; diastolic BP < 60 or > 110mmHg; EKG QTc > 475 msec.
- In regard to vulnerable patient populations, persons with dementia, minors (<age 19), the elderly (>age 65), prisoners and the terminally ill are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
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.
Read the detailed description
Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Adjunctive asenapine
- Keywords
- PTSD, Posttraumatic Stress Disorder, Asenapine, Adjunctive, antidepressant, neuroleptic
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive asenapineDrug
Also called asenapine, Saphris
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.
| Study group | Role | What they receive |
|---|---|---|
| antidepressant plus asenapine | Experimental | adjunctive asenapine Receives: Drug: Adjunctive asenapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, week 4, 8, and 12
Secondary outcomes (1)
Change From Baseline in Brief Psychiatric Rating Scale (BPRS)
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.
Measured: Baseline, week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lori Davis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Forest Laboratories
- Responsible party
- Sponsor-investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa Research & Education Advancement Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587118
- Sponsor's protocol ID
- 00156
- Status last verified
- Jun 2019
- First submitted
- 25 Apr 2012
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing of individual participant data
Publications
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.
PubMed 27738377
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01587118
- Acronym / sponsor ID
- 00156
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Posttraumatic Stress Disorder, Asenapine, Adjunctive, antidepressant, neuroleptic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lori Davis, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Forest Laboratories
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antidepressant plus asenapine | Experimental | Drug: Adjunctive asenapineadjunctive asenapine |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive asenapineAlso: asenapine, Saphrisparticipants 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. | Drug | antidepressant plus asenapine |
Primary outcome
Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total
Time frame: baseline, week 4, 8, and 12
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.
1 secondary outcome
Change From Baseline in Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, week 4, 8, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27738377Pilkinton 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.
- Individual participant dataSharing planned: No. No sharing of individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori L Davis, MD principal investigator
Tuscaloosa Research & Education Advancement Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjunctive asenapine in people with Posttraumatic Stress Disorder, run by Lori Davis, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total (time frame: baseline, week 4, 8, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.