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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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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