# Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)

> **NCT01360645** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 826 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** OPC-34712 + ADT
- **DRUG:** Placebo + ADT
- **DRUG:** Placebo + ADT

## Key facts

- **NCT ID:** NCT01360645
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-07
- **Primary completion:** 2013-05
- **Final completion:** 2013-06
- **Target enrollment:** 826 (ACTUAL)
- **Last updated:** 2015-11-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01360645

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01360645, "Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01360645. Licensed CC0.

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