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NCT01838681 · ClinicalTrials.gov registry record · Phase 3
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,986
- Enrollment target
NCT01838681: Completed Phase 3 study, sponsored by H. Lundbeck A/S.
NCT01838681 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 1,986 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838681, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,986 participants
- Enrollment target
Study Summary
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Primary Outcome
Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Interventions
- DRUG Placebo
- DRUG ADT
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,986 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01838681 record still lists
NCT01838681 is an interventional study that assigns participants to a tested intervention. Its 1,986 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01838681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01838681 about?
NCT01838681 is a clinical study titled "Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment". To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
What is the current status of trial NCT01838681?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,986 participants. The study started on 2013-06. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01838681?
The interventions under investigation include: Placebo (DRUG), ADT (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT01838681?
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 NCT01838681's enrollment target sits among peer trials
1,986 106th of 2000 higher than 1,895 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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