Post-traumatic Stress DisorderPhase 3NCT01987960
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
A Phase 3 study testing Brexpiprazole in people with Post-traumatic Stress Disorder and PTSD, run by H. Lundbeck A/S at 59 sites in 9 countries.
Trial summary
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder, PTSD
- What is being tested?
- Brexpiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 59 sitesin 9 countries
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.
- The reported duration of the PTSD is at least 3 months.
Who cannot join
- The index traumatic event that led to development of PTSD took place more than 15 years before screening.
- The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study.
- The patient is at significant suicidal risk.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
59 sites in 9 countries.
59 sites in 9 countries
United States22 sites
US003
Austin, Texas, 78731
US002
Bradenton, Florida, 34201
US009
Cincinnati, Ohio, 45219
US005
Dayton, Ohio, 45417
US006
Gainesville, Florida, 32607
US012
Indianapolis, Indiana, 46260
US016
Jacksonville, Florida, 32256
US019
Las Vegas, Nevada, 89102
US004
Los Angeles, California, 90024
US025
Los Angeles, California, 90102
US011
Memphis, Tennessee, 38119
US007
Nashua, New Hampshire, 03060
US014
Norristown, Pennsylvania, 19403
US020
North Miami, Florida, 33161
US010
Portland, Oregon, 97210
US024
Riverside, California, 92504
US021
Roslindale, Massachusetts, 02131
US015
San Diego, California, 90103
US008
San Diego, California, 92123
US026
Seattle, Washington, 98104
US017
Tampa, Florida, 33609
US001
The Bronx, New York, 10467
South Africa9 sites
ZA006
Bloemfontein
ZA002
Cape Town
ZA003
Cape Town
ZA004
Cape Town
ZA005
Cape Town
ZA008
Durban
ZA007
Port Elizabeth
ZA001
Pretoria
ZA009
Pretoria
Finland6 sites
FI002
Helsinki
FI003
Helsinki
FI001
Kuopio
FI006
Oulu
FI005
Tampere
FI004
Turku
About this study
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
- Conditions
- Post-traumatic Stress Disorder, PTSD
- Being tested
- Placebo, Brexpiprazole
- 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.
PlaceboDrug
Once daily, tablets, orally
BrexpiprazoleDrug
1 to 3 mg/day, once daily dose, tablets, orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Receives: Drug: Placebo |
| Brexpiprazole | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms Using CAPS-2 Total Score
Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.
Measured: Period 2: Baseline to Week 12 (of randomized period)
Secondary outcomes (1)
Global Clinical Impression Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Measured: Period 2: Baseline to Week 12 (of randomized period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns
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.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987960
- Sponsor's protocol ID
- 14865A
- Other IDs
- 2012-004982-41
- Status last verified
- Jan 2017
- First submitted
- 13 Nov 2013
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01987960
- Acronym / sponsor ID
- 14865A
- Conditions
- Post-traumatic Stress Disorder, PTSD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns
- Enrolment
- 417 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) |
| Brexpiprazole | Experimental | Drug: BrexpiprazoleBrexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.
- The reported duration of the PTSD is at least 3 months.
Key exclusion criteria (4 listed)
- The index traumatic event that led to development of PTSD took place more than 15 years before screening.
- The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study.
- The patient is at significant suicidal risk.
- Other inclusion and exclusion criteria may apply.
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 |
|---|---|---|
| PlaceboOnce daily, tablets, orally | Drug | Placebo |
| Brexpiprazole1 to 3 mg/day, once daily dose, tablets, orally | Drug | Brexpiprazole |
Primary outcome
PTSD Symptoms Using CAPS-2 Total Score
Time frame: Period 2: Baseline to Week 12 (of randomized period)
Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.
1 secondary outcome
Global Clinical Impression Severity of Illness (CGI-S) Score
Time frame: Period 2: Baseline to Week 12 (of randomized period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
59 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brexpiprazole in people with Post-traumatic Stress Disorder and PTSD, run by H. Lundbeck A/S at 59 sites in 9 countries.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, South Africa, Finland, France, Italy and 4 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Mar 2017). 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?
PTSD Symptoms Using CAPS-2 Total Score (time frame: Period 2: Baseline to Week 12 (of randomized period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.