A Study of Ketamine in Patients With Treatment-resistant Depression
NCT ID: NCT01627782
Last Updated: 2025-04-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2012-08-06
2013-09-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
NCT02610712
Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
NCT01667926
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
NCT01582945
Ketamine in Adolescents With Treatment-Resistant Depression
NCT02078817
Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)
NCT01920555
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo 3 times/week
Placebo
Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.
Ketamine 3 times/week
Ketamine
Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
Ketamine 2 times/week
Ketamine
Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
Placebo 2 times/week
Placebo
Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.
Ketamine
Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Charleston, South Carolina, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
A Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KETIVTRD2002
Identifier Type: OTHER
Identifier Source: secondary_id
CR100886
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.