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NCT01942785 · ClinicalTrials.gov registry record · Phase 3
Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT01942785: Completed Phase 3 study, sponsored by H. Lundbeck A/S.
NCT01942785 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01942785, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.
Primary Outcome
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01942785 record still lists
NCT01942785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT01942785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01942785 about?
NCT01942785 is a clinical study titled "Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy". To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.
What is the current status of trial NCT01942785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2013-10.
What interventions are being tested in trial NCT01942785?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT01942785?
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 NCT01942785's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 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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