Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02400346 · ClinicalTrials.gov registry record · Phase 3

Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

A Phase 3 study, sponsored by H. Lundbeck A/S.

Completed
Registry status
Phase 3
Development phase
132
Enrollment target

NCT02400346: Completed Phase 3 study, sponsored by H. Lundbeck A/S.

NCT02400346 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02400346, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.

COMPLETED
Registry status
Phase 3
Development phase
132 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Primary Outcome

Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit

Interventions

  • DRUG ADT
  • DRUG Adjunct brexpiprazole

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2015-03
Est. Completion 2016-06
Phase Phase 3
H. Lundbeck A/S

72 total trials

What the finished NCT02400346 record still lists

NCT02400346 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (83% lower).

The record links to 0 conditions, and to 2 interventions - of which ADT is the first listed.

NCT02400346 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02400346 about?

NCT02400346 is a clinical study titled "Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment". The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

What is the current status of trial NCT02400346?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2015-03. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02400346?

The interventions under investigation include: ADT (DRUG), Adjunct brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT02400346?

This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02400346's enrollment target sits among peer trials

132 1588th of 2000 higher than 408 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01766297 · 132 participants · Phase 2

    Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

  • NCT04002947 · 132 participants · Phase 2

    Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

  • NCT04128189 · 132 participants · Phase 3

    Shingrix in Renal Transplant Recipients

  • NCT04199780 · 132 participants · NA

    Effects of tDCS Combined With CBI on Postsurgical Pain

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT02400346, the US trial registry maintained by the National Library of Medicine. NCT02400346 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.