Rapid Antidepressant Effects of Ketamine in Major Depression
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| ClinicalTrials.gov Identifier: NCT00088699 |
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Recruitment Status :
Completed
First Posted : August 2, 2004
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
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Sponsor:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other |
| Conditions |
Depression Mood Disorders Major Depresssion |
| Interventions |
Drug: Ketamine Drug: Placebo |
| Enrollment | 67 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | MDD: Ketamine, Then Placebo | MDD: Placebo, Then Ketamine | Healthy Volunteers: Ketamine, Then Placebo | Healthy Volunteers:Placebo, Then Ketamine |
|---|---|---|---|---|
 Arm/Group Description |
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg. | Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg | Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg | Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg |
| Period Title: Infusion 1 | ||||
| Started | 23 | 19 | 13 | 12 |
| Completed | 22 | 19 | 12 | 10 |
| Not Completed | 1 | 0 | 1 | 2 |
| Period Title: Infusion 2 | ||||
| Started | 19 | 18 | 11 | 11 |
| Completed | 19 | 18 | 11 | 10 |
| Not Completed | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Healthy Volunteer | Major Depressive Disorder (MDD) | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Healthy volunteer patients | Patients diagnosed with Major Depressive Disorder (MDD) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 25 | 42 | 67 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 42 participants | 67 participants | |
| <=18 years |
0 0.0%
|
0 0.0%
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0 0.0%
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| Between 18 and 65 years |
25 100.0%
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41 97.6%
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66 98.5%
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| >=65 years |
0 0.0%
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1 2.4%
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1 1.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 42 participants | 67 participants | |
| Female |
16 64.0%
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25 59.5%
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41 61.2%
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| Male |
9 36.0%
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17 40.5%
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26 38.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 42 participants | 67 participants | |
| Hispanic or Latino |
4 16.0%
|
3 7.1%
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7 10.4%
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|
| Not Hispanic or Latino |
21 84.0%
|
39 92.9%
|
60 89.6%
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|
| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 42 participants | 67 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 4.0%
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1 2.4%
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2 3.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
6 24.0%
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3 7.1%
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9 13.4%
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| White |
16 64.0%
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36 85.7%
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52 77.6%
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| More than one race |
1 4.0%
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2 4.8%
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3 4.5%
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| Unknown or Not Reported |
1 4.0%
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0 0.0%
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1 1.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Zarate, Carlos |
| Organization: | National Institute of Mental Health |
| Phone: | +1 301 451 0861 |
| EMail: | zaratec@mail.nih.gov |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) |
| ClinicalTrials.gov Identifier: | NCT00088699 |
| Other Study ID Numbers: |
040222 04-M-0222 |
| First Submitted: | July 30, 2004 |
| First Posted: | August 2, 2004 |
| Results First Submitted: | July 30, 2018 |
| Results First Posted: | October 12, 2018 |
| Last Update Posted: | October 12, 2018 |