CompletedPhase 2ketamine

A Study of Ketamine in Patients With Treatment-resistant Depression

Sponsored by Janssen Research & Development, LLC

NCT ID
NCT01627782
Target Enrollment
68 participants
Start Date
2012-08-06
Est. Completion
2013-09-12

About This Study

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

Conditions Studied

Major Depressive Disorder

Interventions

  • Placebo
  • Ketamine

Eligibility

Age:18 Years - 64 Years
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (13)

Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Centennial, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Atlanta, Georgia, United States
Rockville, Maryland, United States
Marlton, New Jersey, United States
New York, New York, United States
Allentown, Pennsylvania, United States

+3 more locations

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source