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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH068376 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to evaluate the effects of a single low dose of the D2/D3 antagonist amisulpride on reward processing. More generally, this study will test the role of dopamine (a naturally occurring brain chemical) in depression.
Hypotheses:
Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve performance in a behavioral task assessing learning from feedback and (2) boost activation in reward-related brain regions.
Through an integration of a functional magnetic resonance imaging (fMRI) approach coupled with a pharmacological challenge, the goal of the current study will be to investigate the role of dopamine in MDD. Participants in this research will include 36 MDD subjects and 36 demographically matched healthy participants recruited from the community by Dr. Pizzagalli's laboratory at McLean Hospital's Center for Depression, Anxiety and Stress Research. This study will include two sessions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD-amisulpride | Active Comparator | Subjects experiencing a current episode of major depression who are randomized to receive amisulpride |
|
| MDD-placebo | Placebo Comparator | Subjects experiencing a current episode of major depression who are randomized to receive placebo |
|
| HC-amisulpride | Active Comparator | Subjects having no history of mental disorder (healthy controls, HC) who are randomized to receive amisulpride |
|
| HC-placebo | Placebo Comparator | Subjects having no history of mental disorder who are randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amisulpride | Drug | single low-dose pharmacological challenge, 50 mg amisulpride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on PST Reward Learning | This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials. | administered after scan |
| Effect on PST Penalty Learning | This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from penalties during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from penalty trials. | administered after scan |
| Effect on Caudate Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Scan session |
| Effect on NAcc Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Scan session |
| Putamen Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Scan session |
| Effect on Caudate Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after Reward outcomes. Positive values indicate an increase in activation relative to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Caudate-dACC Connectivity After Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between caudate and dorsal anterior cingulate cortex (dACC) in response to reward outcomes | During scan session |
| Effect on NAcc-MCC Connectivity After Reward |
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Inclusion Criteria:
Inclusion Criteria for subjects with Major Depressive Disorder (MDD):
Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnostic criteria for MDD, diagnosed with the use of the Structured Clinical Interview for DSM Disorders (SCID);
Written informed consent;
Both genders and all ethnic origins, age between 18 and 45;
A baseline score > 16 on the Hamilton Rating Scale for Depression (HRSD) 17-item version;
Right-handed.
Absence of any psychotropic medications for at least 2 weeks:
Inclusion Criteria for Control Subjects:
Exclusion Criteria:
Exclusion Criteria for All Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Diego A Pizzagalli, PhD | McLean Hospital, Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27771973 | Background | Admon R, Kaiser RH, Dillon DG, Beltzer M, Goer F, Olson DP, Vitaliano G, Pizzagalli DA. Dopaminergic Enhancement of Striatal Response to Reward in Major Depression. Am J Psychiatry. 2017 Apr 1;174(4):378-386. doi: 10.1176/appi.ajp.2016.16010111. Epub 2016 Oct 24. | |
| 31784354 | Derived | Liu Y, Admon R, Mellem MS, Belleau EL, Kaiser RH, Clegg R, Beltzer M, Goer F, Vitaliano G, Ahammad P, Pizzagalli DA. Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):163-172. doi: 10.1016/j.bpsc.2019.10.002. Epub 2019 Oct 22. |
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An assessment visit was conducted prior to the drug-challenge visit. Subjects had a diagnostic interview (SCID) and preliminary physical exam, provided a blood sample for lab tests, and completed surveys, to determine eligibility. Those meeting eligibility criteria were scheduled for a drug+scanning visit where randomization occurred.
Participants were recruited at McLean Hospital (Belmont, MA) and Massachusetts General Hospital (MGH; Boston, MA) between February, 2012, and September, 2015. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Prior to Randomization | All Participants went through Assessment, prior to randomization. |
| FG001 | MDD-amisulpride | Subjects experiencing a current episode of major depression who are randomized to receive amisulpride |
| FG002 | MDD-placebo | Subjects experiencing a current episode of major depression who are randomized to receive placebo |
| FG003 | HC-amisulpride | Subjects having no history of mental disorder who are randomized to receive amisulpride |
| FG004 | HC-placebo | Subjects having no history of mental disorder who are randomized to receive placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assessment and Scheduling |
|
| ||||||||||||||||||||||||
| Drug+Scanning Visit |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MDD-amisulpride | Subjects experiencing a current episode of major depression who received amisulpride |
| BG001 | MDD-placebo | Subjects experiencing a current episode of major depression who received placebo |
| 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 | Effect on PST Reward Learning | This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials. | Reward-learning results are missing for 7 subjects | Posted | Mean | Standard Deviation | Effect size (Beta) | administered after scan |
|
Full study duration (2012-2015)
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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 | MDD-amisulpride | Subjects experiencing a current episode of major depression who received amisulpride |
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The choice of a 50-mg dose of amisulpride was based on animal work showing low doses potentiate striatal dopamine release, have strong hedonic effects, and increase the incentive value of environmental cues. Higher doses may have different results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diego Pizzagalli, Ph.D. | McLean Hospital | 617-855-4230 | dap@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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There were two groups of subjects: currently experiencing a major depressive episode, or normal health controls. The groups were matched for age, gender, and race. Within each group, half of the subjects were assigned to receive the study drug (amisulpride) and half to receive a placebo.
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| placebo | Drug | single-dose placebo capsule |
|
| During scan session |
| Effect on NAcc Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after reward outcomes. Positive values indicate an increase in activation relative to baseline. | During scan session |
| Effect on Putamen Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation (beta) after reward outcomes. Positive values indicate an increase in activation relative to baseline. | During scan session |
This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between nucleus accumbens (NAcc) and mid-cingulate cortex (MCC) in response to reward outcomes. |
| During scan session |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Received Drug Challenge |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | HC-amisulpride | Subjects having no history of mental disorder who received amisulpride |
| BG003 | HC-placebo | Subjects having no history of mental disorder who received placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Educ-yrs | Years of Education | Mean | Standard Deviation | years |
|
| Menstrual phase | Menstrual phase when scanned (females only) | Percent among females only | Count of Participants | Participants |
|
| HRSD | Hamilton Rating Scale for Depression (HRSD), 17 item. Range: 0 (no symptoms) to 52 (maximum symptom severity) Clinical categories for total score: 0-7: absent; 8-13: mild; 14-19: moderate; 20-25: severe; 26-52: very severe. | 5 missing values | Mean | Standard Deviation | units on a scale |
|
| MDD SCID rating | Diagnostic rating of Major Depressive Disorder (MDD): 3=Meets Criteria; 2=Subthreshold; 1=Absent | Mean | Standard Deviation | units on a scale |
|
| # MDEs | Number of discrete major depressive episodes (MDE). | Applies to MDD subjects only | Mean | Standard Deviation | Episodes |
|
| Length_MDE | Length of the current major depressive episode (months) | Statistics include MDD subjects only | Mean | Standard Deviation | months |
|
| Patients with comorbid anxiety disorder | Number of subjects with current comorbid Anxiety Disorders | Count of Participants | Participants |
|
| Patients with past anxiety disorder | Number of subjects with past comorbid Anxiety Disorders | Count of Participants | Participants |
|
| TCI Total | Total score on the Novelty-Seeking (NS) subset of the Temperament and Character Inventory (TCI). The NS subset consists of 35 items from the full 240-item TCI survey. ITEMS: statements people might use to describe their attitudes, opinions, interests, and other personal feelings. Item responses are on a 5-point scale of 1 (definitely false) to 5 (definitely true); Range: 35-175. Higher scores indicate higher Novelty-Seeking temperament. | Mean | Standard Deviation | units on a scale |
|
| TCI NS-1 | TCI NS subscale 1 - "Exploratory excitability v stoic rigidity"; 10 items, Range: 10-50; Higher scores indicate higher degree of exploratory excitability | Mean | Standard Deviation | units on a scale |
|
| TCI NS-2 | TCI NS subscale 2 - "Impulsiveness v reflection"; 9 items, Range: 9-45; Higher scores indicate higher degree of impulsiveness | Mean | Standard Deviation | units on a scale |
|
| TCI NS-3 | TCI NS subscale 3 - "Extravagance v reserve" ; 9 items, Range: 9-45; Higher scores indicate higher degree of extravagance. | Mean | Standard Deviation | units on a scale |
|
| TCI NS-4 | TCI NS subscale 4 - "Disorderliness v regimentation" ; 7 items, Range: 7-35; Higher scores indicate higher degree of disorderliness. | Mean | Standard Deviation | units on a scale |
|
| BIS attention-1 | Attention subscale (first order) of the Barratt Impulsiveness Scale (BIS); 5 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 5-20, higher scores indicate less stable attention | Mean | Standard Deviation | units on a scale |
|
| BIS cognitive instability | Cognitive Instability subscale (first order) of the BIS; 3 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 3-12, higher scores indicate less stable cognition | Mean | Standard Deviation | units on a scale |
|
| BIS motor-1 | Motor subscale (first order) of the BIS; 7 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 7-28, higher scores indicate greater motor impulsivity | Mean | Standard Deviation | units on a scale |
|
| BIS perseverance | Perseverance subscale (first order) of the BIS; 4 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 4-16, higher scores indicate more perseveration | Mean | Standard Deviation | units on a scale |
|
| BIS self control | Self-control subscale (first order) of the BIS; 6 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 6-24, higher scores indicate less self-control | Mean | Standard Deviation | units on a scale |
|
| BIS cognitive complexity | Cognitive Complexity subscale (first order) of the BIS; 5 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); range 5-20, higher scores indicate greater difficulty with complexity | Mean | Standard Deviation | units on a scale |
|
| BIS Attention-2 | Attentional Impulsivity subscale (second order) of the BIS; Sum of the Attention-1 and Cognitive Instability subscales; Range 8-32, higher scores indicate less ability to control attention | Mean | Standard Deviation | units on a scale |
|
| BIS Motor-2 | Motor impulsivity subscale (second order) of the BIS; Sum of the Motor-1 and Perseverance subscales; Range 11-44, higher scores indicate more impulsive movement | Mean | Standard Deviation | units on a scale |
|
| BIS Non-planning-2 | Non-planning subscale (second order) of the BIS; Sum of the Self-control and Cognitive Complexity subscales; Range 11-44, higher scores indicate less ability to guide according to a plan | Mean | Standard Deviation | units on a scale |
|
| MASQ total | Mood and Anxiety Symptom Questionnaire (MASQ), short form. Measures the severity of anxiety and depressive symptoms. 62 items, rating of how much you have experienced certain feelings, emotions, or behaviors in the past week; item responses are on a 5-point scale from 1 (not at all) to 5 (extremely). Range: 62-310; higher scores indicates more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| MASQ GDA | General Distress-Anxiety (GDA) subscale of the MASQ. 11 items on a scale of 1 to 5. Range: 11-55, higher scores indicate greater severity of anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| MASQ GDD | General Distress-Depression (GDD) subscale of the MASQ. 12 items on a scale of 1 to 5. Range: 12-60, higher scores indicate greater severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| MASQ AA | Anxious Arousal (AA) subscale of the MASQ; 17 items on a scale of 1 to 5; Range: 17-85, higher scores indicate greater severity of anxious arousal symptoms. | Mean | Standard Deviation | units on a scale |
|
| MASQ AD | Anhedonic Depression (AD) subscale of the MASQ; 22 items on a scale of 1 to 5; Range: 22-110, higher scores indicate greater severity of anhedonic symptoms. | Mean | Standard Deviation | units on a scale |
|
| RSES_Total | Rosenberg Self Esteem Scale (RSES) total score. A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a Likert scale ranging from strongly disagree (0) to strongly agree (3); scores on negative feelings are inverted. Range: 0-30, higher scores indicate higher self-esteem. | Mean | Standard Deviation | units on a scale |
|
| Defeat Scale | The level of defeat-related feelings the participant has felt in the past week. 16 items, rated on a scale from 0 (never) to 4 (always). Range: 0 to 64; higher scores indicate greater feelings of defeat. | Mean | Standard Deviation | units on a scale |
|
| BDI-II | Beck Depression Inventory-II (BDI-II). Measures the presence and severity of 21 depressive symptoms during the past two weeks, on a scale from 0 (none, or no change) to 3 (persistent, or worsening). Range: 0 to 63. Higher scores indicate greater symptom severity. Clinical categories for total score: 0-14: absent; 14-19: mild; 20-28: moderate; 29-63: severe. | Mean | Standard Deviation | units on a scale |
|
| SHPS total | Snaith Hamilton Pleasure Scale (SHPS); assesses capacity to experience pleasure (hedonic tone). Items: 35 statements that a person might enjoy a particular activity. Item responses are on a 4-point scale of 1 (Strongly agree) to 4 (Strongly disagree). Range: 35-140, higher scores indicate greater anhedonia. | Mean | Standard Deviation | units on a scale |
|
| SHPS-low | Number of "low" responses (value is 1 or 2) on the SHPS. Range: 0-14; higher scores indicate better hedonic tone. | Mean | Standard Deviation | Count of 'low' responses (1 or 2) |
|
| AES | Apathy Evaluation Scale (AES), assesses apathy during the past 4 weeks. Items: 18 statements about a person feeling interest, initiative, or motivation. Item responses are on a 4-point scale of 1 (Not at all true) to 4 (Very true). Range: 18-72, lower scores indicate greater apathy. | Mean | Standard Deviation | units on a scale |
|
| Current smokers | Number of current smokers per group | Count of Participants | Participants |
|
| Past smokers | Number of subject who were smokers in the past | Count of Participants | Participants |
|
| Current drinkers | Number of subjects who drink alcoholic beverages | Count of Participants | Participants |
|
| Drinks in past 24hrs | Average number of drinks in the past 24 hours | Mean | Standard Deviation | equivalent shot/can/glasses |
|
| Usual caffeine (mg) | Amount of caffeine consumed on a normal day in milligrams | Mean | Standard Deviation | milligrams |
|
| Caffeine today (mg) | Amount of caffeine consumed on the day of testing in milligrams | Mean | Standard Deviation | milligrams |
|
| OG002 | HC-amisulpride | Subjects having no history of mental disorder who received amisulpride |
| OG003 | HC-placebo | Subjects having no history of mental disorder who received placebo |
|
|
| Primary | Effect on PST Penalty Learning | This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from penalties during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from penalty trials. | Penalty-learning results are missing for 7 subjects | Posted | Mean | Standard Deviation | Effect size (Beta) | administered after scan |
|
|
|
| Primary | Effect on Caudate Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Data are missing for 8 subjects due to poor MRI quality. | Posted | Mean | Standard Deviation | Effect size (Beta) | Scan session |
|
|
|
| Primary | Effect on NAcc Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Data are missing for 8 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | Scan session |
|
|
|
| Primary | Putamen Response to Cues | This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline. | Data are missing for 9 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | Scan session |
|
|
|
| Primary | Effect on Caudate Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after Reward outcomes. Positive values indicate an increase in activation relative to baseline. | Data are missing for 9 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | During scan session |
|
|
|
| Primary | Effect on NAcc Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after reward outcomes. Positive values indicate an increase in activation relative to baseline. | Data are missing for 10 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | During scan session |
|
|
|
| Primary | Effect on Putamen Response to Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation (beta) after reward outcomes. Positive values indicate an increase in activation relative to baseline. | Data are missing for 9 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | During scan session |
|
|
|
| Secondary | Effect on Caudate-dACC Connectivity After Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between caudate and dorsal anterior cingulate cortex (dACC) in response to reward outcomes | Data missing for 8 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | During scan session |
|
|
|
| Secondary | Effect on NAcc-MCC Connectivity After Reward | This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between nucleus accumbens (NAcc) and mid-cingulate cortex (MCC) in response to reward outcomes. | Data missing for 8 subjects due to poor MRI quality | Posted | Mean | Standard Deviation | Effect size (Beta) | During scan session |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | MDD-placebo | Subjects experiencing a current episode of major depression who received placebo | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | HC-amisulpride | Subjects having no history of mental disorder who received amisulpride | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | HC-placebo | Subjects having no history of mental disorder who received placebo | 0 | 14 | 0 | 14 | 0 | 14 |
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| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Luteal |
|
| Unknown |
|
| No comorbid Anxiety Disorder |
|
| Unknown |
|
| No |
|
| Unknown |
|