A Study of Ketamine in Patients With Treatment-resistant Depression
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ClinicalTrials.gov Identifier: NCT01627782 |
Recruitment Status :
Completed
First Posted : June 26, 2012
Results First Posted : August 5, 2016
Last Update Posted : June 2, 2020
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Major Depressive Disorder |
Interventions |
Drug: Placebo Drug: Ketamine |
Enrollment | 68 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 165 participants were screened and 68 participants were randomized into the study. Of these 68 participants randomized, 67 participants received at least 1 dose of the study agent (Intent-To-Treat analysis set). |
Arm/Group Title | Placebo: 2 Times Per Week | Ketamine: 2 Times Per Week | Placebo: 3 Times Per Week | Ketamine: 3 Times Per Week |
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Arm/Group Description | Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks. | Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks. | Participants received IV infusion of placebo 3 times weekly for 4 weeks. | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. |
Period Title: Overall Study | ||||
Started | 17 | 18 | 16 | 17 |
Treated | 16 | 18 | 16 | 17 |
Completed | 1 | 12 | 1 | 11 |
Not Completed | 16 | 6 | 15 | 6 |
Reason Not Completed | ||||
Adverse Event | 1 | 2 | 0 | 1 |
Lack of Efficacy | 11 | 1 | 15 | 2 |
Protocol Violation | 1 | 0 | 0 | 0 |
Withdrawal by Subject | 2 | 1 | 0 | 0 |
Other | 0 | 2 | 0 | 3 |
Randomized But Not Treated | 1 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo: 2 Times Per Week | Ketamine: 2 Times Per Week | Placebo: 3 Times Per Week | Ketamine: 3 Times Per Week | Total | |
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Arm/Group Description | Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks. | Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks. | Participants received IV infusion of placebo 3 times weekly for 4 weeks. | Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 16 | 18 | 16 | 17 | 67 | |
Baseline Analysis Population Description |
The Intent-To-Treat (ITT) analysis set is defined as participants who were randomized and received at least 1 dose of the study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 16 participants | 18 participants | 16 participants | 17 participants | 67 participants | |
40.3 (11.79) | 45.7 (9.58) | 46.1 (10.51) | 43.3 (11.99) | 43.9 (10.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | 18 participants | 16 participants | 17 participants | 67 participants | |
Female |
12 75.0%
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12 66.7%
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9 56.3%
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12 70.6%
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45 67.2%
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Male |
4 25.0%
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6 33.3%
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7 43.8%
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5 29.4%
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22 32.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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USA | Number Analyzed | 16 participants | 18 participants | 16 participants | 17 participants | 67 participants |
16 | 18 | 16 | 17 | 67 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: | Senior Director, Clinical Research |
Organization: | Janssen Research & Development, LLC |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01627782 |
Other Study ID Numbers: |
CR100886 KETIVTRD2002 ( Other Identifier: Janssen Research & Development, LLC ) |
First Submitted: | June 22, 2012 |
First Posted: | June 26, 2012 |
Results First Submitted: | May 10, 2016 |
Results First Posted: | August 5, 2016 |
Last Update Posted: | June 2, 2020 |