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Rapid Antidepressant Effects of Ketamine in Major Depression

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ClinicalTrials.gov Identifier: NCT00088699
Recruitment Status : Completed
First Posted : August 2, 2004
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

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
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
Hide 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
Arm/Group Title Healthy Volunteer Major Depressive Disorder (MDD) Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 42 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
41
  97.6%
66
  98.5%
>=65 years
0
   0.0%
1
   2.4%
1
   1.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 42 participants 67 participants
Female
16
  64.0%
25
  59.5%
41
  61.2%
Male
9
  36.0%
17
  40.5%
26
  38.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 42 participants 67 participants
Hispanic or Latino
4
  16.0%
3
   7.1%
7
  10.4%
Not Hispanic or Latino
21
  84.0%
39
  92.9%
60
  89.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 42 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
1
   2.4%
2
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  24.0%
3
   7.1%
9
  13.4%
White
16
  64.0%
36
  85.7%
52
  77.6%
More than one race
1
   4.0%
2
   4.8%
3
   4.5%
Unknown or Not Reported
1
   4.0%
0
   0.0%
1
   1.5%
1.Primary Outcome
Title MADRS Score - Baseline
Hide Description Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included subjects who were given Ketamine or Placebo.
Arm/Group Title Ketamine - Healthy Volunteers Placebo - Healthy Volunteers Ketamine - MDD Patients Placebo - MDD Patients
Hide Arm/Group Description:
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
Overall Number of Participants Analyzed 24 23 41 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.17  (1.37) 1.48  (1.78) 33.83  (4.23) 31.82  (5.84)
2.Primary Outcome
Title MADRS Score - Day 1 Following Intervention
Hide Description Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included subjects who were given Ketamine or Placebo.
Arm/Group Title Ketamine - Healthy Volunteers Placebo - Healthy Volunteers Ketamine - MDD Patients Placebo - MDD Patients
Hide Arm/Group Description:
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to patients with Major Depressive Disorders (MDD)
Overall Number of Participants Analyzed 22 21 40 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.45  (3.79) 0.67  (1.15) 23.73  (10.32) 30.68  (5.50)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Volunteer: Ketamine MDD: Ketamine Healthy Volunteer: Placebo MDD: Placebo
Hide Arm/Group Description Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg. 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
All-Cause Mortality
Healthy Volunteer: Ketamine MDD: Ketamine Healthy Volunteer: Placebo MDD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/41 (0.00%)   0/23 (0.00%)   0/38 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Volunteer: Ketamine MDD: Ketamine Healthy Volunteer: Placebo MDD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/41 (0.00%)   0/23 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Volunteer: Ketamine MDD: Ketamine Healthy Volunteer: Placebo MDD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/24 (100.00%)   36/41 (87.80%)   8/23 (34.78%)   16/38 (42.11%) 
Cardiac disorders         
Dizziness   19/24 (79.17%)  27/41 (65.85%)  1/23 (4.35%)  0/38 (0.00%) 
Dyspnoea   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Ear and labyrinth disorders         
Auditory disorder   6/24 (25.00%)  7/41 (17.07%)  0/23 (0.00%)  0/38 (0.00%) 
Ear pain   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Motion sickness   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Tinnitus   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Vertigo   1/24 (4.17%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Eye disorders         
Diplopia   1/24 (4.17%)  4/41 (9.76%)  0/23 (0.00%)  0/38 (0.00%) 
Vision blurred   5/24 (20.83%)  11/41 (26.83%)  0/23 (0.00%)  0/38 (0.00%) 
Visual impairment   14/24 (58.33%)  20/41 (48.78%)  0/23 (0.00%)  0/38 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort   2/24 (8.33%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Constipation   0/24 (0.00%)  0/41 (0.00%)  0/23 (0.00%)  1/38 (2.63%) 
Diarrhoea   1/24 (4.17%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Dry mouth   6/24 (25.00%)  5/41 (12.20%)  0/23 (0.00%)  0/38 (0.00%) 
Dysgeusia   1/24 (4.17%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Flatulence   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Mouth ulceration   0/24 (0.00%)  0/41 (0.00%)  0/23 (0.00%)  1/38 (2.63%) 
Nausea   5/24 (20.83%)  4/41 (9.76%)  0/23 (0.00%)  0/38 (0.00%) 
Oropharyngeal pain   0/24 (0.00%)  0/41 (0.00%)  0/23 (0.00%)  1/38 (2.63%) 
Vomiting   3/24 (12.50%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
General disorders         
Decreased appetite   4/24 (16.67%)  5/41 (12.20%)  0/23 (0.00%)  1/38 (2.63%) 
Energy increased   2/24 (8.33%)  3/41 (7.32%)  0/23 (0.00%)  0/38 (0.00%) 
Fatigue   7/24 (29.17%)  2/41 (4.88%)  1/23 (4.35%)  0/38 (0.00%) 
Feeling abnormal   20/24 (83.33%)  32/41 (78.05%)  1/23 (4.35%)  0/38 (0.00%) 
Flushing   2/24 (8.33%)  7/41 (17.07%)  0/23 (0.00%)  0/38 (0.00%) 
Hyperhidrosis   1/24 (4.17%)  3/41 (7.32%)  0/23 (0.00%)  0/38 (0.00%) 
Increased appetite   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  1/38 (2.63%) 
Irritability   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  1/38 (2.63%) 
Oedema   0/24 (0.00%)  0/41 (0.00%)  1/23 (4.35%)  0/38 (0.00%) 
Thirst   1/24 (4.17%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Investigations         
Body temperature decreased   2/24 (8.33%)  6/41 (14.63%)  0/23 (0.00%)  1/38 (2.63%) 
Body temperature increased   4/24 (16.67%)  7/41 (17.07%)  0/23 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms   0/24 (0.00%)  3/41 (7.32%)  2/23 (8.70%)  1/38 (2.63%) 
Nervous system disorders         
Abnormal dreams   1/24 (4.17%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Amnesia   3/24 (12.50%)  5/41 (12.20%)  0/23 (0.00%)  1/38 (2.63%) 
Balance disorder   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Confusional state   6/24 (25.00%)  17/41 (41.46%)  0/23 (0.00%)  0/38 (0.00%) 
Disturbance in attention   15/24 (62.50%)  3/41 (7.32%)  1/23 (4.35%)  0/38 (0.00%) 
Dysarthria   3/24 (12.50%)  4/41 (9.76%)  0/23 (0.00%)  0/38 (0.00%) 
Headache   2/24 (8.33%)  4/41 (9.76%)  1/23 (4.35%)  1/38 (2.63%) 
Hypoaesthesia   14/24 (58.33%)  24/41 (58.54%)  1/23 (4.35%)  0/38 (0.00%) 
Hypokinesia   6/24 (25.00%)  2/41 (4.88%)  0/23 (0.00%)  1/38 (2.63%) 
Insomnia   5/24 (20.83%)  7/41 (17.07%)  2/23 (8.70%)  5/38 (13.16%) 
Paraesthesia   6/24 (25.00%)  9/41 (21.95%)  1/23 (4.35%)  0/38 (0.00%) 
Parosmia   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Psychomotor hyperactivity   1/24 (4.17%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Sedation   8/24 (33.33%)  7/41 (17.07%)  0/23 (0.00%)  3/38 (7.89%) 
Slow speech   6/24 (25.00%)  17/41 (41.46%)  0/23 (0.00%)  0/38 (0.00%) 
Speech disorder   11/24 (45.83%)  20/41 (48.78%)  0/23 (0.00%)  0/38 (0.00%) 
Terminal insomnia   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  2/38 (5.26%) 
Tremor   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Vibratory sense increased   1/24 (4.17%)  5/41 (12.20%)  0/23 (0.00%)  0/38 (0.00%) 
Psychiatric disorders         
Anxiety   2/24 (8.33%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Depression   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Dissociation   12/24 (50.00%)  19/41 (46.34%)  0/23 (0.00%)  0/38 (0.00%) 
Euphoric mood   4/24 (16.67%)  7/41 (17.07%)  0/23 (0.00%)  0/38 (0.00%) 
Fear   1/24 (4.17%)  5/41 (12.20%)  0/23 (0.00%)  0/38 (0.00%) 
Hallucination   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Libido decreased   1/24 (4.17%)  0/41 (0.00%)  0/23 (0.00%)  0/38 (0.00%) 
Premenstrual syndrome   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  1/38 (2.63%) 
Suicidal ideation   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Renal and urinary disorders         
Dysuria   0/24 (0.00%)  2/41 (4.88%)  0/23 (0.00%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough   0/24 (0.00%)  0/41 (0.00%)  0/23 (0.00%)  1/38 (2.63%) 
Nasal congestion   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  1/38 (2.63%) 
Skin and subcutaneous tissue disorders         
Alopecia   0/24 (0.00%)  0/41 (0.00%)  1/23 (4.35%)  0/38 (0.00%) 
Skin irritation   0/24 (0.00%)  0/41 (0.00%)  0/23 (0.00%)  1/38 (2.63%) 
Vascular disorders         
Hypertension   3/24 (12.50%)  6/41 (14.63%)  0/23 (0.00%)  0/38 (0.00%) 
Hypotension   0/24 (0.00%)  1/41 (2.44%)  0/23 (0.00%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Zarate, Carlos
Organization: National Institute of Mental Health
Phone: +1 301 451 0861
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     History of Changes
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