# Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

> **NCT02196506** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 837 (actual)

## Conditions studied

- Depressive Disorder
- Depression
- Depressive Disorder, Major
- Mood Disorders
- Mental Disorders

## Interventions

- **DRUG:** Placebo + ADT
- **DRUG:** Brexpiprazole +ADT

## Key facts

- **NCT ID:** NCT02196506
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-07
- **Primary completion:** 2016-04
- **Final completion:** 2016-05
- **Target enrollment:** 837 (ACTUAL)
- **Last updated:** 2018-08-21

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02196506

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02196506, "Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT02196506. Licensed CC0.

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