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NCT01987960 · ClinicalTrials.gov registry record · Phase 3
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Terminated
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
NCT01987960: Clinical Trial Phase 3 study, sponsored by H. Lundbeck A/S.
NCT01987960 is a Phase 3 study that was terminated before completion, run by H. Lundbeck A/S. The registered enrollment target is 417 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01987960, a Phase 3 study, was terminated before completion, sponsored by H. Lundbeck A/S.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
Study Summary
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
Why NCT01987960 stopped before completion
NCT01987960 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01987960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01987960 about?
NCT01987960 is a clinical study titled "Brexpiprazole as an 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.
What is the current status of trial NCT01987960?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2013-12. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01987960?
The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT01987960?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01987960's enrollment target sits among peer trials
417 902nd of 2000 higher than 1,099 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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