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CompletedPhase 2

A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression

NCT01640080 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 2
Phase
30
Target enrolment
9
Study sites
Outside the US

What it is testing

Summary

The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change from Day 1 (baseline) to Day 2 in the Montgomery Asberg Depression Rating Scale (MADRS) total score in the double-blind treatment phase

    Measured over Day 1 (baseline), Day 2

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Be medically stable on the basis of clinical laboratory tests * Diagnostic for major depressive disorder (MDD) without psychotic features * 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 * Women must be not pregnant; women must be postmenopausal, surgically sterile or, if heterosexually active, practicing a highly effective method of birth control during the study and for 3 months after receiving the last dose of study drug * Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug * Signed informed consent document Exclusion Criteria: * History of, or current signs and symptoms of diseases or conditions that would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments * Has uncontrolled hypertension (systolic blood pressure (SBP)\> 160 mmHg or diastolic blood pressure (DBP)\> 90 mmHg despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment) or any past history of hypertensive crisis * Has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or have positive results at screening * Has a primary diagnosis of current (active) generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa * Has a history or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders or chronic fatigue syndrome * Has had major surgery, (eg, requiring general or local anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study

Where

9 study sites

FacilityCityRegionCountry
DaveBelgium
GhentBelgium
KortenbergBelgium
LedeBelgium
BerlinGermany
Freiburg im BreisgauGermany
MainzGermany
MünchenGermany
GdanskPoland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01640080 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits