Trial · NCT01987960
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
NCT01987960, Phase 3, Terminated, H. Lundbeck A/S; results first posted 2017-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD). Trials, record NCT01987960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01987960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
- NCT number
- NCT01987960
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 417 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Post-traumatic Stress Disorder, PTSD
- Interventions
- Placebo, Brexpiprazole
- First posted
- 2013-11-20
- Last updated
- 2017-03-13
- Other registries' IDs
- eudract:2012-004982-41
- Results first posted
- 2017-03-13
- Limitations and caveats
- As the study was terminated limited efficacy and safety data were collected from the randomized patients. The data are descriptive and the primary and key secondary efficacy analyses were not done.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PTSD Symptoms Using CAPS-2 Total Score | 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. |
| Secondary | Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2: Baseline to Week 12 (of randomized period) | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PTSD Symptoms Using CAPS-2 Total Score | Period 2: Baseline to Week 12 (of randomized period) | Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done | Score | MEAN |
| SECONDARY | Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2: Baseline to Week 12 (of randomized period) | Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done. | Score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PTSD Symptoms Using CAPS-2 Total Score | Period 2 Absolute Mean at Baseline; Placebo and PAR/SER | 82.82 | Standard Deviation 12.94 | Score | |
| PTSD Symptoms Using CAPS-2 Total Score | Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER | 83.43 | Standard Deviation 13.12 | Score | |
| PTSD Symptoms Using CAPS-2 Total Score | Period 2 Absolute Mean at Week 12; Placebo and PAR/SER | 69.67 | Standard Deviation 20.26 | Score | |
| PTSD Symptoms Using CAPS-2 Total Score | Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER | 69.18 | Standard Deviation 18.17 | Score | |
| Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2 Absolute Mean at Baseline; Placebo and PAR/SER | 4.24 | Standard Deviation 0.83 | Score | |
| Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER | 4.54 | Standard Deviation 0.73 | Score | |
| Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2 Absolute Mean at Week 12; Placebo and PAR/SER | 3.73 | Standard Deviation 1.10 | Score | |
| Global Clinical Impression Severity of Illness (CGI-S) Score | Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER | 3.94 | Standard Deviation 0.83 | Score |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Period 1 Placebo and PAR/SER | 417 | |
| Period 1 | STARTED | Period 2 Placebo and PAR/SER (Randomized Period) | 0 | |
| Period 1 | STARTED | Period 2 Brexpiprazole and PAR/SER (Randomized Period) | 0 | |
| Period 1 | STARTED | Period 3 Placebo and PAR/SER | 0 | |
| Period 1 | COMPLETED | Period 1 Placebo and PAR/SER | 231 | |
| Period 1 | COMPLETED | Period 2 Placebo and PAR/SER (Randomized Period) | 0 | |
| Period 1 | COMPLETED | Period 2 Brexpiprazole and PAR/SER (Randomized Period) | 0 | |
| Period 1 | COMPLETED | Period 3 Placebo and PAR/SER | 0 | |
| Period 1 | NOT COMPLETED | Period 1 Placebo and PAR/SER | 186 | |
| Period 1 | NOT COMPLETED | Period 2 Placebo and PAR/SER (Randomized Period) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 | |
| other | Conjunctivitis | Eye disorders | Placebo + PAR/SER (Randomized Period) | 1 | 17 | |
| other | Gastroenteritis | Infections and infestations | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 | |
| other | Gastroenteritis | Infections and infestations | Placebo + PAR/SER (Randomized Period) | 1 | 17 | |
| other | Pharyngitis | Infections and infestations | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 | |
| other | Pharyngitis | Infections and infestations | Placebo + PAR/SER (Randomized Period) | 1 | 17 | |
| other | Upper respiratory tract infection | Infections and infestations | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + PAR/SER (Randomized Period) | 1 | 17 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Brexpiprazole + PAR/SER (Randomized Period) | 2 | 23 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo + PAR/SER (Randomized Period) | 1 | 17 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole + PAR/SER (Randomized Period) | ||
| Total, all-cause mortality | Placebo + PAR/SER (Randomized Period) | ||
| Total, other adverse events | Brexpiprazole + PAR/SER (Randomized Period) | 3 | 23 |
| Total, other adverse events | Placebo + PAR/SER (Randomized Period) | 8 | 17 |
| Total, serious adverse events | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 |
| Total, serious adverse events | Placebo + PAR/SER (Randomized Period) | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Brexpiprazole + PAR/SER (Randomized Period) vs Placebo + PAR/SER (Randomized Period): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01987960
GET https://conductscience.org/api/trials/v1/NCT01987960/flow?page=2