Trial Outcomes & Findings for Binge Eating & Birth Control (NCT NCT04278755)
NCT ID: NCT04278755
Last Updated: 2022-07-26
Results Overview
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
TERMINATED
PHASE2
8 participants
Pre-intervention (week 1) to intervention endpoint (week 12)
2022-07-26
Participant Flow
Participant milestones
| Measure |
Continuous OC
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Binge Eating & Birth Control
Baseline characteristics by cohort
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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Age, Continuous
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22.0 years
STANDARD_DEVIATION 3.2 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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7 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants that started the study medication and completed the pre-intervention and intervention endpoints.
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Outcome measures
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
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-0.43 episodes/week
Standard Deviation 1.27
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants who started the study medication and completed the pre-intervention and intervention endpoints
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention.
Outcome measures
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
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-6.60 score on a scale
Standard Deviation 7.11
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable.
Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Outcome measures
| Measure |
Continuous OC
n=6 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
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.0423 percentage signal change
Standard Deviation .26
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable.
Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Outcome measures
| Measure |
Continuous OC
n=6 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Putamen
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.02 percentage signal change
Standard Deviation .10
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Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Caudate
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-.012 percentage signal change
Standard Deviation .11
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable.
Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Outcome measures
| Measure |
Continuous OC
n=6 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
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.01 percentage signal change
Standard Deviation .15
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PRIMARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants that started the study medication and completed the pre-intervention and intervention endpoints.
The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention.
Outcome measures
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
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.01 k value
Standard Deviation .013
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SECONDARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants that started the study medication and completed the pre-intervention and intervention endpoints.
Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention.
Outcome measures
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
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1.60 score on a scale
Standard Deviation 2.30
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SECONDARY outcome
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)Population: Participants that started the study medication and completed the pre-intervention and intervention endpoints.
The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention.
Outcome measures
| Measure |
Continuous OC
n=7 Participants
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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|---|---|
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Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score
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1.43 score on a scale
Standard Deviation 5.41
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Adverse Events
Continuous OC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous OC
n=8 participants at risk
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Drospirenone-Ethinyl Estradiol Oral Tablet: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
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Reproductive system and breast disorders
Menstrual Bleeding
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50.0%
4/8 • Number of events 7 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Endocrine disorders
Bloating
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Reproductive system and breast disorders
Breast Tenderness
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Gastrointestinal disorders
Nausea
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Reproductive system and breast disorders
Cramps
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37.5%
3/8 • Number of events 4 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Psychiatric disorders
Irritability
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Reproductive system and breast disorders
Spotting
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100.0%
8/8 • Number of events 14 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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General disorders
Lethargic
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12.5%
1/8 • Number of events 1 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Psychiatric disorders
Anxiety
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25.0%
2/8 • Number of events 4 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Psychiatric disorders
Low Mood
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12.5%
1/8 • Number of events 1 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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General disorders
Drowsiness
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Psychiatric disorders
Mood Change
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12.5%
1/8 • Number of events 1 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Nervous system disorders
Headache
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25.0%
2/8 • Number of events 2 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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General disorders
Insomnia
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12.5%
1/8 • Number of events 1 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Metabolism and nutrition disorders
Decreased Overeating
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12.5%
1/8 • Number of events 1 • Adverse event data was tracked over a participant's time in the protocol (approximately 84 days).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
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Additional Information
Jessica Baker, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place