A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

Summary

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Conditions

• Depressive Disorder, Major

Interventions

DRUG

Esketamine 28 mg

Esketamine will be self-administered at a dose of 28 mg as nasal spray.

DRUG

Esketamine 56 mg

Esketamine will be self-administered at a dose of 56 mg as nasal spray.

DRUG

Esketamine 84 mg

Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.

DRUG

Quetiapine XR 50 mg

Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

DRUG

Quetiapine XR 100 mg

Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

DRUG

Quetiapine XR 150 mg

Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

DRUG

SSRI/SNRI

Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).

Sponsors & Collaborators

• Janssen-Cilag International NV

  lead INDUSTRY

Principal Investigators

• Janssen-Cilag International NV Clinical Trials · Janssen-Cilag International NV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-21

Primary Completion

2022-01-20

Completion

2022-07-15

FDA Drug

Yes

Countries

• Argentina
• Austria
• Belgium
• Brazil
• Bulgaria
• Czechia
• Denmark
• Finland
• Germany
• Greece
• Hungary
• Israel
• Kazakhstan
• Malaysia
• Netherlands
• Norway
• Poland
• Portugal
• South Africa
• South Korea
• Sweden
• Taiwan
• Turkey (Türkiye)
• United Arab Emirates

Study Locations