Trial Outcomes & Findings for Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder (NCT NCT02461927)
NCT ID: NCT02461927
Last Updated: 2025-04-10
Results Overview
Our primary analysis (severity of depression) was to compare the proportions of subjects with clinical response in symptoms of major depressive disorder (response defined as a 50% or greater improvement from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores) at the end-of-treatment time point (Day 21, after 4th infusion, T+240 minutes).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Day 21 (after 4th infusion, 240 minutes)
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
Ketamine + Naltrexone
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
|
Ketamine + Placebo
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Placebo (Psychoactive Placebo Midazolam) + Placebo
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
22
|
|
Overall Study
COMPLETED
|
16
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects receiving at least one infusion were analyzed
Baseline characteristics by cohort
| Measure |
Ketamine + Naltrexone
n=20 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
|
Ketamine + Placebo
n=19 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Placebo (Psychoactive Placebo Midazolam) + Placebo
n=19 Participants
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants • Subjects receiving at least one infusion were analyzed
|
50.0 years
STANDARD_DEVIATION 10.1 • n=7 Participants • Subjects receiving at least one infusion were analyzed
|
41.9 years
STANDARD_DEVIATION 13.5 • n=5 Participants • Subjects receiving at least one infusion were analyzed
|
45.3 years
STANDARD_DEVIATION 12.8 • n=4 Participants • Subjects receiving at least one infusion were analyzed
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
4 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
5 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
13 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
15 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
14 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
45 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
18 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
14 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
7 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
39 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
0 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
3 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
5 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
8 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
2 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
1 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
5 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
8 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
1 Participants
n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
2 Participants
n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
3 Participants
n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS) score, mean (SD)
|
27.8 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
30.3 units on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
30.3 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
29.4 units on a scale
STANDARD_DEVIATION 6.4 • n=4 Participants • Subjects receiving at least one infusion treatment were analyzed.
|
PRIMARY outcome
Timeframe: Day 21 (after 4th infusion, 240 minutes)Population: Subjects who completed the outcome measure on Day 21 (after 4th infusion, 240 minutes)
Our primary analysis (severity of depression) was to compare the proportions of subjects with clinical response in symptoms of major depressive disorder (response defined as a 50% or greater improvement from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores) at the end-of-treatment time point (Day 21, after 4th infusion, T+240 minutes).
Outcome measures
| Measure |
Ketamine + Naltrexone
n=16 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
|
Ketamine + Placebo
n=11 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Placebo (Psychoactive Placebo Midazolam) + Placebo
n=15 Participants
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
|---|---|---|---|
|
Number of Participants With 50% or Greater Improvement in MADRS Scores From Baseline
|
15 Participants
|
9 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: The total number of participants analyzed is inconsistent with the total number of participants reported in the same arm in the Participant Flow---because there is a lot of missing data in the TLFB.
Alcohol consumption was measured using the Time Line Follow Back (TLFB) method. The rates of complete abstinence from alcohol across visits 3 (day 0) through visit 7 (day 28) were compared among the three study groups.
Outcome measures
| Measure |
Ketamine + Naltrexone
n=11 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
|
Ketamine + Placebo
n=12 Participants
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Placebo (Psychoactive Placebo Midazolam) + Placebo
n=13 Participants
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
|---|---|---|---|
|
Rate of Complete Abstinence From Alcohol
|
3 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
Ketamine + Naltrexone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ketamine + Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo (Psychoactive Placebo Midazolam) + Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine + Naltrexone
n=20 participants at risk
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Ketamine + Naltrexone: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
|
Ketamine + Placebo
n=19 participants at risk
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Ketamine + Placebo: Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
Placebo (Psychoactive Placebo Midazolam) + Placebo
n=19 participants at risk
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Placebo (psychoactive placebo midazolam) + Placebo: Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
|
|---|---|---|---|
|
General disorders
Blurred or double vision
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Chest pain, tightness, or discomfort
|
0.00%
0/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
General confusion
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Confusion as to time, place, person
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Cough
|
15.0%
3/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
31.6%
6/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Difficult, troubled breath or shortness of breath
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Difficult, burning, pain, frequent urge to urinate
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Difficulty with swallowing
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
General dizziness
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Dizziness, faintness, lightheadedness upon rising
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Dream-like state
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Fast, slow, irregular heartbeat
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Flushing or redness of skin
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Irregular, fast, slow, or shallow breathing
|
0.00%
0/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Itching
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Loss of appetite
|
15.0%
3/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Nausea
|
15.0%
3/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Pain at IV site
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Pale or blue lips, fingernails, skin
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Puffiness or swelling of eyelids or eyes
|
15.0%
3/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Puffiness or swelling around eyes, face, lips, tongue
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Seeing, hearing, feeling things that are not there
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Skin rash
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Sweating
|
15.0%
3/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Unusually warm skin
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Unusual excitement, nervousness, restlessness
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Unusual tiredness or weakness
|
0.00%
0/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
15.8%
3/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
36.8%
7/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Vomiting
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Weight loss
|
20.0%
4/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Headache
|
20.0%
4/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
31.6%
6/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Drowsiness
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
31.6%
6/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Anxiety
|
20.0%
4/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
21.1%
4/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
31.6%
6/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Tiredness
|
20.0%
4/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
31.6%
6/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Breast Pain
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Painful menstrual periods
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
10.5%
2/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Missed menstrual periods
|
10.0%
2/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
|
General disorders
Excessive menstrual bleeding
|
5.0%
1/20 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
5.3%
1/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
0.00%
0/19 • During the study period (8 weeks)
Adverse events were collected using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) method.
|
Additional Information
Dr. Gihyun Yoon
VA CT Healthcare System, Yale University
Phone: (203) 932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place