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Halted prematurely due to COVID-19-related enrollment challenges.
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| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
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This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.
Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4).
The objective of this study is to examine the impact of ovarian hormone stabilization, through the continuous administration of oral contraceptives (OCs) for 3-months, on brain activation in response to reward and eating behaviors in women who binge eat (n=15) using functional magnetic resonance imaging (fMRI) and behavioral testing. OCs work by suppressing ovulation, thereby reducing E2 and P4 changes that occur pre- and post- ovulation. Because the traditional 21/7 regimen of OC administration (21 active pills followed by 7 days of inactive pills) allows follicles to begin to develop, this leads to the secretion of endogenous E2, and then E2 withdrawal once active pills begin again. This does not result in consistent stabilization. Thus, this study will use OCs in a continuous manner, with no inactive pills.
Participants will complete fMRI imaging and self-report questionnaires prior to OC administration and at the end of OC administration. The investigators will examine within-subject changes that occur in these measures with OC administration. The primary hypothesis is that continuous OC treatment will have a beneficial/stabilizing effect on outcomes of interest. Specifically, symptomatology may decrease from OC use. Results will ultimately provide the pilot data necessary for larger mechanistic trials.
The specific aims are to:
Aim 1: Quantify the effect of ovarian hormone stabilization on eating behaviors in women with binge eating.
Aim 2: Examine the effect of ovarian hormone stabilization on response to reward using fMRI and self-report questionnaires in women with binge eating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous OC | Experimental | Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drospirenone-Ethinyl Estradiol Oral Tablet | Drug | 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score | 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. |
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Inclusion Criteria
Participants will include women ages 18-34 with a current Diagnostic and Statistical Manual (DSM-5) diagnosis of a binge eating syndrome and a regular menstrual cycle. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.
Exclusion Criteria
Men will not be included in this study given the stated purpose to study ovarian hormones.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Baker, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. 2013, Washington, DC: American Psychiatric Press. | ||
| 23585773 | Background | Baker JH, Girdler SS, Bulik CM. The role of reproductive hormones in the development and maintenance of eating disorders. Expert Rev Obstet Gynecol. 2012 Nov 1;7(6):573-583. doi: 10.1586/eog.12.54. | |
| 17038206 |
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Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication upon reasonable request.
Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency | 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. | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | Posted | Mean | Standard Deviation | episodes/week | Pre-intervention (week 1) to intervention endpoint (week 12) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Menstrual Bleeding | Reproductive system and breast disorders | Systematic Assessment |
The study was terminated early due to the inability to recruit eligible participants therefore only a very small number of participants have available data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Baker, PhD | University of North Carolina at Chapel Hill | 984-974-3929 | jhbaker@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2022 | Jun 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| D001068 | Feeding and Eating Disorders |
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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| Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
| Pre-intervention (week 1) to intervention endpoint (week 12) |
| Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score | 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. | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score | 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. | Participants who started the study medication and completed the pre-intervention and intervention endpoints | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| Primary | Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. | 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. | Posted | Mean | Standard Deviation | percentage signal change | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| Primary | Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. | 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. | Posted | Mean | Standard Deviation | percentage signal change | Pre-intervention (week 1) to intervention endpoint (week 12) |
|
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| Primary | Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | 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. | 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. | Posted | Mean | Standard Deviation | percentage signal change | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| Primary | Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k | 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. | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | Posted | Mean | Standard Deviation | k value | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| Secondary | Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score | 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. | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 1) to intervention endpoint (week 12) |
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| Secondary | Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score | 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. | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 1) to intervention endpoint (week 12) |
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| Bloating | Endocrine disorders | Systematic Assessment |
|
| Breast Tenderness | Reproductive system and breast disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Cramps | Reproductive system and breast disorders | Systematic Assessment | Menstrual-type cramps |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Spotting | Reproductive system and breast disorders | Systematic Assessment |
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| Lethargic | General disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Low Mood | Psychiatric disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Mood Change | Psychiatric disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Decreased Overeating | Metabolism and nutrition disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |