Efficacy and Safety of Esketamine in the Treatment of Patients With Treatment Resistant Major Depressio

• Conditions: Treatment Resistant Major Depression; MedDRA version: 14.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-005992-17-PL
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-31
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Be a man or woman, 18 to 64 years of age, inclusive.
- Be medically stable on the basis of clinical laboratory tests performed at screening.
- Meet Diagnostic and Statistical Manual of Mental Disorders – Fourth Edition (DSM-IV-TR) diagnostic criteria for recurrent MDD, without psychotic features (DSM-IV, 296.32, or 296.33),
- Have an inadequate response to at least 1 antidepressant in the current episode of depression and at least one other inadequate treatment response to an antidepressant either in the current episode or in a previous episode.
- Have an IDS-C30 total score = 34 at Screening and Day -1.
- Hospitalized or agreed to be hospitalized from Day -1 through the completion of study procedures on Day 2 and from Day 3 through the completion of study procedures on Day 4.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Has a history of, or current signs and symptoms of, liver or renal insufficiency; hypothyroidism or hyperthyroidism, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled may participate in the study.
- Has uncontrolled hypertension (SBP> 160 mmHg or DBP > 90 mmHg despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment) at Screening; or any past history of hypertensive crisis.
- Has a history of previous non-response of depressive symptoms to ketamine/esketamine.
- Has any contraindication to the use of esketamine, per local prescribing information.
- Has not responded to previous treatment with electroconvulsive therapy (ECT).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified