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CompletedPhase 2Results posted

A Study of Ketamine in Patients With Treatment-resistant Depression

NCT01627782 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 2
Phase
68
Target enrolment
13
Study sites
12 US states

What it is testing

Summary

The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).

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 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15

    Measured over Baseline (Day 1) and Day 15

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 performed at screening * Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features * Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant * Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score \>= 40 at screening and predose at Day 1 * Inpatient or agreed to be admitted to the clinic on each dosing day Exclusion Criteria: * Has uncontrolled hypertension * Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, 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 known allergies, hypersensitivity, or intolerance to ketamine or its excipients * Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff

Where

13 study sites

FacilityCityRegionCountry
BirminghamAlabamaUnited States
Little RockArkansasUnited States
CentennialColoradoUnited States
HartfordConnecticutUnited States
New HavenConnecticutUnited States
AtlantaGeorgiaUnited States
RockvilleMarylandUnited States
MarltonNew JerseyUnited States
New YorkNew YorkUnited States
AllentownPennsylvaniaUnited States
CharlestonSouth CarolinaUnited States
DallasTexasUnited States
Salt Lake CityUtahUnited States

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.

NCT01627782 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