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

NCT01640080 | Completed Phase 2

• 3 other identifiers: CR100843ESKETIVTRD20012011-005992-17
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Treatment resistant depression; Depression; Esketamine

Outcome Measures

Primary Outcomes (1)

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

  The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

  Day 1 (baseline), Day 2

Secondary Outcomes (13)

• Change from Day 1 (baseline) to Day 4 in Major Depressive Disorder (MDD) symptoms using the Montgomery Asberg Depression Rating Scale (MADRS) total score in the double-blind treatment phase

  Day 1 (baseline), Day 4

• Change from Day 1 (baseline) to Day 35 in Major Depressive Disorder (MDD) symptoms using the Montgomery Asberg Depression Rating Scale (MADRS) total score during the posttreatment phase

  Day 1 (baseline), Day 35

• The number of patients who have a reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score of >50% versus baseline on Day 2

  Day 1 (baseline), Day 2

• Change from Day 1 (baseline) to Day 4 in Major Depressive Disorder (MDD) symptoms using the Quick Inventory of Depressive Symptomatology-Self Report- 14-Item (QIDS-SR14)

  Day 1 (baseline), Day 4

• Change from Day 1 (baseline) to Day 14 in Major Depressive Disorder (MDD) symptoms using the Quick Inventory of Depressive Symptomatology-Self Report-16-item (QIDS-SR16)

  Day 1 (baseline), Day 14

Study Arms (3)

Esketamine (Group 1)

EXPERIMENTAL

Drug: Esketamine

Esketamine (Group 2)

EXPERIMENTAL

Drug: Esketamine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Esketamine DRUG

Type= exact number, number= 0.20, unit= mg/kg, form= intravenous infusion, route= intravenous use. One single intravenous infusion of esketamine 0.20 mg/kg administered on Day 1 and Day 4.

Esketamine (Group 1)

Placebo DRUG

Form= intravenous infusion, route= intravenous use. One single placebo intravenous infusion administered on Day 1 and Day 4.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (9)

Unknown Facility

Dave, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Kortenberg, Belgium

Location

Unknown Facility

Lede, Belgium

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Gdansk, Poland

Location

Related Publications (3)

• Lewis S, Romano C, De Bruecker G, Murrough JW, Shelton R, Singh JB, Jamieson C. Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression. Patient. 2019 Oct;12(5):527-537. doi: 10.1007/s40271-019-00369-8.

  PMID: 31270774 DERIVED

• Johnson KM, Devine JM, Ho KF, Howard KA, Saretsky TL, Jamieson CA. Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response. J Clin Psychiatry. 2016 Dec;77(12):1681-1686. doi: 10.4088/JCP.15m10253.

  PMID: 28086004 DERIVED

• Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.

  PMID: 26707087 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Depression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: June 27, 2012
• Primary Completion: June 3, 2013
• Study Completion: June 3, 2013
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

BE (4); PL (1); DE (4)