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Funding ended
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Participants will be randomized to either Mifepristone 600mg once daily for seven days or Placebo tablet once daily for seven days. Rating scales, vital signs, cortisol levels will be collected for evaluation.
Mifepristone is an antagonist of type II glucocorticoid (GR-II) receptors, which has shown safety, efficacy, and good tolerability in the treatment of psychotic major depression (PMD). Like BPD, Hypothalamic-pituitary-adrenal (HPA) axis hyper-responsiveness appears to play a role in PMD pathophysiology. Belanoff et al. (2002) hypothesized that mifepristone causes a normalizing "resetting" of HPA axis rhythm, accounting for its efficacy in PMD. Mifepristone produces a marked (2- to 3- fold) compensatory increase in central cortisol levels via its antagonism of GR-II receptors. This consequent central cortisol elevation may then be able to counteract abnormally heightened corticotrophin-releasing hormone (CRH) activity via enhanced negative feedback mechanisms.
This is a proof of principle study of mifepristone in the treatment of individuals with BPD and histories of childhood abuse, which aims to translate neurobiological research concerning HPA axis abnormalities in BPD into a novel clinical intervention for patients. This project will also explore an innovative approach to the structure of pharmacotherapy for BPD. Specifically, we will employ the circumscribed (finite) drug administration period used in prior studies of mifepristone in neuropsychiatric illness, which differs from the current clinical practice of indefinite daily usage of medications. We hypothesize that mifepristone will beneficially impact stress response neurobiology and consequently ameliorate associated BPD symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | Mifepristone 600mg once daily x 7 days |
|
| Placebo | Placebo Comparator | Matching placebo tablets one daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | Mifepristone 600mg (3x200mg tablets) once daily for seven days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Symptom Change | To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. | Baseline to 7 days of study medication |
| Durable Symptom Change | To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. | 7 days of study medication to 21 days after discontinuation of study medication |
| Number of Participants With Possibly and Probably Related Adverse Events | To determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure. | Baseline to 21 days after discontinuation of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. |
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Inclusion Criteria:
18-64 years of age at study entry
Female or Male
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of borderline personality disorder (confirmed by SCID II) with history of abuse prior to the age of 18.
Able to provide informed consent
Inpatient or outpatient
Clinical stability as defined by:
Female subjects of childbearing potential must test negative for pregnancy at screening visit and agree to use the double-barrier method, as defined by 2 physical barriers such as a condom, diaphragm, or cervical occlusive cap, coupled with an additional barrier such as spermicidal foam, gel, film, cream or suppository for the duration of the study. Subjects having undergone a hysterectomy or bilateral oophorectomy or other form of female sterilization or patients having been medically confirmed to be post-menopausal, would not require any other method of contraception.
Minimum severity of a total score > 3 on the The Clinical Global Impression severity (CGI-S)
Must agree not to consume tonic water and grapefruit or grapefruit product for 3 days prior to beginning medication and until the final study visit
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larue D Carter Memorial Hospital | Indianapolis | Indiana | 46222 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | Mifepristone 600mg once daily x 7 days mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days |
| FG001 | Placebo | Matching placebo tablets one daily Placebo: 3 tablets once daily for seven days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone | Mifepristone 600mg once daily x 7 days mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days |
| BG001 | Placebo | Matching placebo tablets one daily Placebo: 3 tablets once daily for seven days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Rapid Symptom Change | To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to 7 days of study medication |
|
Screening through 21 days after study medication was discontinued
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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 | Mifepristone | Mifepristone 600mg once daily x 7 days mifepristone: Mifepristone 600mg (3x200mg tablets) once daily for seven days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foreign body in urethra | Renal and urinary disorders | Systematic Assessment | Hospitalization for a foreign body in the urethra |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal electrocardiogram | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Breier | IndianaU | 317-880-8495 | abreier@iupui.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 | Sep 22, 2015 | Dec 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D010554 | Personality Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Drug |
3 tablets once daily for seven days |
|
| Levels of Cortisol | To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
| Baseline (Visit 2) |
| Symptom Change - BPRS | The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity. | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
| Symptom Change - Borderline Checklist | The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity. | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
| Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | Baseline (Visit 2) |
| Metacognitive Capacity | The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition. | Baseline, 21 days after discontinuation of study medication |
| Symptom Change - CGI-S | The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity. | Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) |
| Symptom Change - CGI-I | The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity. | 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) |
| Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. | 7 days of study medication (Visit 4) |
| Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. | 21 days after discontinuation of study medication (Visit 6) |
| Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | 7 days of study medication (Visit 4) |
| Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | 21 days after discontinuation of study medication (Visit 6) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 | Number | participants |
|
| OG001 | Placebo | Matching placebo tablets one daily Placebo: 3 tablets once daily for seven days |
|
|
| Primary | Durable Symptom Change | To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | 7 days of study medication to 21 days after discontinuation of study medication |
|
|
|
| Primary | Number of Participants With Possibly and Probably Related Adverse Events | To determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure. | Posted | Count of Participants | Participants | Baseline to 21 days after discontinuation of study medication |
|
|
|
| Primary | Levels of Cortisol | To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement | Posted | Mean | Standard Deviation | mcg/dL | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Visit 2) |
|
|
|
| Secondary | Symptom Change - BPRS | The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - Borderline Checklist | The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Visit 2) |
|
|
|
| Secondary | Metacognitive Capacity | The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition. | The IPII assessment was added to the study midway through the study therefore, the first 10 subjects did not have this assessments. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 21 days after discontinuation of study medication |
|
|
|
| Secondary | Symptom Change - CGI-S | The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - CGI-I | The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity. | The CGI-I is measured at visits after baseline, there was 1 subject taking Placebo who discontinued prior to Visit 4 and therefore was not included in analysis. | Posted | Mean | Standard Deviation | Scores on a scale | 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | 7 days of study medication (Visit 4) |
|
|
|
| Secondary | Symptom Change - BPDSI Subscales | Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| Secondary | Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | 7 days of study medication (Visit 4) |
|
|
|
| Secondary | Symptom Change - SCL-90-R | The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. | Posted | Mean | Standard Deviation | Scores on a scale | 21 days after discontinuation of study medication (Visit 6) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Placebo | Matching placebo tablets one daily Placebo: 3 tablets once daily for seven days | 0 | 12 | 1 | 12 | 10 | 12 |
|
| Abdominal bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atopic Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Bug Bites | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cramping | Reproductive system and breast disorders | Systematic Assessment |
|
| Decreased Appetite | General disorders | Systematic Assessment |
|
| Decreased Concentration | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dog Bite Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry Eyes | Eye disorders | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Exacerbation of borderline personality disorder | Psychiatric disorders | Systematic Assessment |
|
| Exhaustion | General disorders | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Hand tremor | General disorders | Systematic Assessment |
|
| Headache/migraine | General disorders | Systematic Assessment |
|
| Heaviness in legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hemorrhoids | Renal and urinary disorders | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased appetite | General disorders | Systematic Assessment |
|
| influenza | General disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| lactation | Reproductive system and breast disorders | Systematic Assessment |
|
| lump in throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| menstural bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| mouth sores | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pre-existing restless leg syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Shakiness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sinus congestion | General disorders | Systematic Assessment |
|
| Somnolence | General disorders | Systematic Assessment |
|
| Toothache | General disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| worsening acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| Cortisol Level - 7 days after disc of study med |
|
| Cortisol Level - 21 days after disc study med |
|
| BPDSI Subscale Score - Identity |
|
| BPDSI Subscale Score - Impulsivity |
|
| BPDSI Subscale Score - Parasuicidal Behavior |
|
| BPDSI Subscale Score - Affective Instability |
|
| BPDSI Subscale Score - Emptiness |
|
| BPDSI Subscale Score - Outbursts of Anger |
|
| BPDSI Sub. Score-Dissociation & Paranoid Ideation |
|
| BPRS - 7 days after disc of study med |
|
| BPRS - 21 days after disc study med |
|
| BPD Checklist - 7 days after disc of study med |
|
| BPD Checklist - 21 days after disc study med |
|
| SCL-90-R - Interpersonal Sensitivity |
|
| SCL-90-R - Depression |
|
| SCL-90-R - Anxiety |
|
| SCL-90-R - Hostility |
|
| SCL-90-R - Phobic Anxiety |
|
| SCL-90-R - Paranoid Ideation |
|
| SCL-90-R - Psychoticism |
|
| SCL-90-R - Global Severity Index |
|
| SCL-90-R - Positive Symptom Total |
|
| SCL-90-R - Positive Symptom Distress Index |
|
| IIPI - Understanding Others - Baseline |
|
| IIPI-Understanding Others-21 days after dis meds |
|
| IIPI - Decentration - Baseline |
|
| IIPI-Decentration-21 days after dis meds |
|
| IIPI - Mastery - Baseline |
|
| IIPI-Mastery-21 days after dis meds |
|
| IIPI - Total - Baseline |
|
| IIPI-Total-21 days after dis meds |
|
| CGI-S - 21 days after disc of study med |
|
| BPDSI Subscale Score - Identity |
|
| BPDSI Subscale Score - Impulsivity |
|
| BPDSI Subscale Score - Parasuicidal Behavior |
|
| BPDSI Subscale Score - Affective Instability |
|
| BPDSI Subscale Score - Emptiness |
|
| BPDSI Subscale Score - Outbursts of Anger |
|
| BPDSI Sub. Score-Dissociation & Paranoid Ideation |
|
| BPDSI Subscale Score - Identity |
|
| BPDSI Subscale Score - Impulsivity |
|
| BPDSI Subscale Score - Parasuicidal Behavior |
|
| BPDSI Subscale Score - Affective Instability |
|
| BPDSI Subscale Score - Emptiness |
|
| BPDSI Subscale Score - Outbursts of Anger |
|
| BPDSI Sub. Score-Dissociation & Paranoid Ideation |
|
| SCL-90-R - Interpersonal Sensitivity |
|
| SCL-90-R - Depression |
|
| SCL-90-R - Anxiety |
|
| SCL-90-R - Hostility |
|
| SCL-90-R - Phobic Anxiety |
|
| SCL-90-R - Paranoid Ideation |
|
| SCL-90-R - Psychoticism |
|
| SCL-90-R - Global Severity Index |
|
| SCL-90-R - Positive Symptom Total |
|
| SCL-90-R - Positive Symptom Distress Index |
|
| SCL-90-R - Interpersonal Sensitivity |
|
| SCL-90-R - Depression |
|
| SCL-90-R - Anxiety |
|
| SCL-90-R - Hostility |
|
| SCL-90-R - Phobic Anxiety |
|
| SCL-90-R - Paranoid Ideation |
|
| SCL-90-R - Psychoticism |
|
| SCL-90-R - Global Severity Index |
|
| SCL-90-R - Positive Symptom Total |
|
| SCL-90-R - Positive Symptom Distress Index |
|