Trial Outcomes & Findings for Rapid Antidepressant Effects of Ketamine in Major Depression (NCT NCT00088699)
NCT ID: NCT00088699
Last Updated: 2018-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
MDD: Ketamine, Then Placebo
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
|
MDD: Placebo, Then Ketamine
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
|
Healthy Volunteers: Ketamine, Then Placebo
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
|
Healthy Volunteers:Placebo, Then Ketamine
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
|
|---|---|---|---|---|
|
Infusion 1
STARTED
|
23
|
19
|
13
|
12
|
|
Infusion 1
COMPLETED
|
22
|
19
|
12
|
10
|
|
Infusion 1
NOT COMPLETED
|
1
|
0
|
1
|
2
|
|
Infusion 2
STARTED
|
19
|
18
|
11
|
11
|
|
Infusion 2
COMPLETED
|
19
|
18
|
11
|
10
|
|
Infusion 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Antidepressant Effects of Ketamine in Major Depression
Baseline characteristics by cohort
| Measure |
Healthy Volunteer
n=25 Participants
Healthy volunteer patients
|
Major Depressive Disorder (MDD)
n=42 Participants
Patients diagnosed with Major Depressive Disorder (MDD)
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analyses included subjects who were given Ketamine or Placebo.
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.
Outcome measures
| Measure |
Ketamine - Healthy Volunteers
n=24 Participants
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
|
Placebo - Healthy Volunteers
n=23 Participants
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
|
Ketamine - MDD Patients
n=41 Participants
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)
|
Placebo - MDD Patients
n=38 Participants
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)
|
|---|---|---|---|---|
|
MADRS Score - Baseline
|
1.17 units on a scale
Standard Deviation 1.37
|
1.48 units on a scale
Standard Deviation 1.78
|
33.83 units on a scale
Standard Deviation 4.23
|
31.82 units on a scale
Standard Deviation 5.84
|
PRIMARY outcome
Timeframe: Day 1Population: The analyses included subjects who were given Ketamine or Placebo.
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.
Outcome measures
| Measure |
Ketamine - Healthy Volunteers
n=22 Participants
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
|
Placebo - Healthy Volunteers
n=21 Participants
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg to healthy volunteer patients
|
Ketamine - MDD Patients
n=40 Participants
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)
|
Placebo - MDD Patients
n=38 Participants
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)
|
|---|---|---|---|---|
|
MADRS Score - Day 1 Following Intervention
|
2.45 units on a scale
Standard Deviation 3.79
|
0.67 units on a scale
Standard Deviation 1.15
|
23.73 units on a scale
Standard Deviation 10.32
|
30.68 units on a scale
Standard Deviation 5.50
|
Adverse Events
Healthy Volunteer: Ketamine
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
MDD: Ketamine
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Healthy Volunteer: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MDD: Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteer: Ketamine
n=24 participants at risk
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
|
MDD: Ketamine
n=41 participants at risk
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
|
Healthy Volunteer: Placebo
n=23 participants at risk
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
|
MDD: Placebo
n=38 participants at risk
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
|
|---|---|---|---|---|
|
Cardiac disorders
Dizziness
|
79.2%
19/24 • 28 days
|
65.9%
27/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Ear and labyrinth disorders
Auditory disorder
|
25.0%
6/24 • 28 days
|
17.1%
7/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Eye disorders
Diplopia
|
4.2%
1/24 • 28 days
|
9.8%
4/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Eye disorders
Vision blurred
|
20.8%
5/24 • 28 days
|
26.8%
11/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Eye disorders
Visual impairment
|
58.3%
14/24 • 28 days
|
48.8%
20/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
2/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
6/24 • 28 days
|
12.2%
5/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Dysgeusia
|
4.2%
1/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
20.8%
5/24 • 28 days
|
9.8%
4/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Decreased appetite
|
16.7%
4/24 • 28 days
|
12.2%
5/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
General disorders
Energy increased
|
8.3%
2/24 • 28 days
|
7.3%
3/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Fatigue
|
29.2%
7/24 • 28 days
|
4.9%
2/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Feeling abnormal
|
83.3%
20/24 • 28 days
|
78.0%
32/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Flushing
|
8.3%
2/24 • 28 days
|
17.1%
7/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Hyperhidrosis
|
4.2%
1/24 • 28 days
|
7.3%
3/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Increased appetite
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
General disorders
Irritability
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
General disorders
Oedema
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
General disorders
Thirst
|
4.2%
1/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Investigations
Body temperature decreased
|
8.3%
2/24 • 28 days
|
14.6%
6/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Investigations
Body temperature increased
|
16.7%
4/24 • 28 days
|
17.1%
7/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24 • 28 days
|
7.3%
3/41 • 28 days
|
8.7%
2/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Nervous system disorders
Abnormal dreams
|
4.2%
1/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Amnesia
|
12.5%
3/24 • 28 days
|
12.2%
5/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Confusional state
|
25.0%
6/24 • 28 days
|
41.5%
17/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Disturbance in attention
|
62.5%
15/24 • 28 days
|
7.3%
3/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Dysarthria
|
12.5%
3/24 • 28 days
|
9.8%
4/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • 28 days
|
9.8%
4/41 • 28 days
|
4.3%
1/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Nervous system disorders
Hypoaesthesia
|
58.3%
14/24 • 28 days
|
58.5%
24/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Hypokinesia
|
25.0%
6/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Nervous system disorders
Insomnia
|
20.8%
5/24 • 28 days
|
17.1%
7/41 • 28 days
|
8.7%
2/23 • 28 days
|
13.2%
5/38 • 28 days
|
|
Nervous system disorders
Paraesthesia
|
25.0%
6/24 • 28 days
|
22.0%
9/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Parosmia
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Psychomotor hyperactivity
|
4.2%
1/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Sedation
|
33.3%
8/24 • 28 days
|
17.1%
7/41 • 28 days
|
0.00%
0/23 • 28 days
|
7.9%
3/38 • 28 days
|
|
Nervous system disorders
Slow speech
|
25.0%
6/24 • 28 days
|
41.5%
17/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Speech disorder
|
45.8%
11/24 • 28 days
|
48.8%
20/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Terminal insomnia
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
5.3%
2/38 • 28 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Nervous system disorders
Vibratory sense increased
|
4.2%
1/24 • 28 days
|
12.2%
5/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Dissociation
|
50.0%
12/24 • 28 days
|
46.3%
19/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Euphoric mood
|
16.7%
4/24 • 28 days
|
17.1%
7/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Fear
|
4.2%
1/24 • 28 days
|
12.2%
5/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Libido decreased
|
4.2%
1/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Psychiatric disorders
Premenstrual syndrome
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • 28 days
|
4.9%
2/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
4.3%
1/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/24 • 28 days
|
0.00%
0/41 • 28 days
|
0.00%
0/23 • 28 days
|
2.6%
1/38 • 28 days
|
|
Vascular disorders
Hypertension
|
12.5%
3/24 • 28 days
|
14.6%
6/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • 28 days
|
2.4%
1/41 • 28 days
|
0.00%
0/23 • 28 days
|
0.00%
0/38 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place