Trial Outcomes & Findings for GATE: Generalized Anxiety - A Treatment Evaluation (NCT NCT01912287)
NCT ID: NCT01912287
Last Updated: 2020-06-22
Results Overview
Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
226 participants
Primary outcome timeframe
Biweekly from weeks 0 through 12
Results posted on
2020-06-22
Participant Flow
Participant milestones
| Measure |
Yoga
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
90
|
43
|
|
Overall Study
COMPLETED
|
60
|
67
|
28
|
|
Overall Study
NOT COMPLETED
|
33
|
23
|
15
|
Reasons for withdrawal
| Measure |
Yoga
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
|---|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
1
|
|
Overall Study
No-show
|
0
|
0
|
1
|
|
Overall Study
Dissatisfaction with assigned treatment
|
4
|
2
|
1
|
|
Overall Study
Felt treatment no longer needed
|
0
|
1
|
0
|
|
Overall Study
Life circumstances
|
4
|
2
|
0
|
|
Overall Study
Lost Interest
|
1
|
0
|
0
|
|
Overall Study
Uknown reason - subject drop out
|
5
|
7
|
3
|
|
Overall Study
Missed Assesment
|
1
|
1
|
1
|
|
Overall Study
Scheduling/change in availability
|
17
|
10
|
8
|
Baseline Characteristics
GATE: Generalized Anxiety - A Treatment Evaluation
Baseline characteristics by cohort
| Measure |
Yoga
n=93 Participants
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
n=90 Participants
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
n=43 Participants
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 13.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian and Native Hawaiian or Pacific Islander
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
79 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Biweekly from weeks 0 through 12Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
Outcome measures
| Measure |
Yoga
n=93 Participants
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
n=90 Participants
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
n=43 Participants
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
|---|---|---|---|
|
Proportion of Participants With Treatment Response
|
0.54 Proportion of participants
|
0.71 Proportion of participants
|
0.33 Proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 6 , 12 and 6 month follow upOutcome measures
Outcome data not reported
Adverse Events
Yoga
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy (CBT)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Stress Education
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Yoga
n=93 participants at risk
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
n=90 participants at risk
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
n=43 participants at risk
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
|---|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
Other adverse events
| Measure |
Yoga
n=93 participants at risk
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
Yoga: 12 sessions, mindfulness components
|
Cognitive Behavioral Therapy (CBT)
n=90 participants at risk
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
|
Stress Education
n=43 participants at risk
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Stress Education: Active control group (12 sessions)
|
|---|---|---|---|
|
Reproductive system and breast disorders
Amenorrhea
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Anxiety
|
17.2%
16/93 • Number of events 16 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
10.0%
9/90 • Number of events 9 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
7.0%
3/43 • Number of events 3 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.2%
2/93 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Depression
|
2.2%
2/93 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
4.4%
4/90 • Number of events 4 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
4.7%
2/43 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
Headache
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.2%
2/90 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Skin and subcutaneous tissue disorders
Hives
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Infections and infestations
Infection
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Insomnia
|
2.2%
2/93 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
4.7%
2/43 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
5.4%
5/93 • Number of events 5 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
5.6%
5/90 • Number of events 5 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.3%
1/43 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Mental Distress
|
4.3%
4/93 • Number of events 4 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
3.3%
3/90 • Number of events 3 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.3%
1/43 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Nightmares
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Gastrointestinal disorders
Stomach Pain
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
Tingling
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Nervous system disorders
Vertigo
|
2.2%
2/93 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Eye disorders
Vision Abnormal
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Metabolism and nutrition disorders
Weight Loss
|
1.1%
1/93 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
Assault
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Bulimia
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
Faint
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
Flu
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.2%
2/90 • Number of events 2 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Blood and lymphatic system disorders
Lymph Nodes Enlarged
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
1.1%
1/90 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/43 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
General disorders
pain
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
3.3%
3/90 • Number of events 3 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.3%
1/43 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
|
Psychiatric disorders
Mood Change
|
0.00%
0/93 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
0.00%
0/90 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
2.3%
1/43 • Number of events 1 • 37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place