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This study will investigate the use of adjunctive pregnenolone for the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnenolone (Arm 1) | Experimental | Pregnenolone |
|
| Placebo (Arm 2) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone | Drug | Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Component of the SF-36 | These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline. | Baseline to week 4, and Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) | These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E. Marx, MD MA | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
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170 participants enrolled; 142 participants were randomized after a 2-week placebo lead-in phase. The remaining 28 randomized participants were withdrawn prior to week 4 post-randomization for various reasons - including medication changes during the study (exclusionary) and participants unavailable for continued contact.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnenolone (Arm 1) | Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days |
| FG001 | Placebo (Arm 2) | Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
28 of the 170 participants were withdrawn from the study prior to reaching week 4 post-randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnenolone (Arm 1) | Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days |
| BG001 | Placebo (Arm 2) |
| 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 | Physical Component of the SF-36 | These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline. | Change in the Physical Component Score of the SF-36. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | Posted | Mean | Standard Error | score on a scale | Baseline to week 4, and Baseline to week 8 |
|
Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
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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 | Pregnenolone (Arm 1) | Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant death by homicide | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold Extremities | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Marx, MD MA | Durham VA Medical Center | 919-286-0411 | 3626 | marx0001@mc.duke.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 | Feb 20, 2015 | Apr 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D059352 | Musculoskeletal Pain |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011284 | Pregnenolone |
| ID | Term |
|---|---|
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days |
|
| Baseline to week 4, and Baseline to week 8 |
| Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A) | These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline. | Baseline to week 4, and Baseline to week 8 |
| Multidimensional Fatigue Inventory (MFI) | These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline. | Baseline to week 4, and Baseline to week 8 |
| Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R) | These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline. | Baseline to week 4, and Baseline to week 8 |
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
| 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 |
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| Region of Enrollment | Count of Participants | Participants |
|
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days |
| OG001 | Placebo (Arm 2) | Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days |
|
|
| Secondary | Brief Pain Inventory (BPI) | These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline. | Change in the average pain rating over the last 24 hours, and the magnitude of interference resulting from that pain. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | Posted | Mean | Standard Error | score on a scale | Baseline to week 4, and Baseline to week 8 |
|
|
|
| Secondary | Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A) | These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline. | Change in the Tower of London Score of the BAC-A. Some subjects did not reach week 8 of the study. | Posted | Mean | Standard Error | score on a scale | Baseline to week 4, and Baseline to week 8 |
|
|
|
| Secondary | Multidimensional Fatigue Inventory (MFI) | These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline. | Total score of the MFI-20. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | Posted | Mean | Standard Error | score on a scale | Baseline to week 4, and Baseline to week 8 |
|
|
|
| Secondary | Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R) | These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline. | Average Global Severity Index score of the SCL-90. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | Posted | Mean | Standard Error | score on a scale | Baseline to week 4, and Baseline to week 8 |
|
|
|
| 1 |
| 82 |
| 1 |
| 82 |
| 69 |
| 82 |
| EG001 | Placebo (Arm 2) | Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days | 0 | 88 | 0 | 88 | 73 | 88 |
| Palpitations | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| Peripheral Edema | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint Pain/Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Pain/Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Akathisia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Increased Motor Activity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Leg Shaking | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Decreased Appetite | Nervous system disorders | Systematic Assessment |
|
| Increased Appetite | Nervous system disorders | Systematic Assessment |
|
| Dry Mouth | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine Headache | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Increased Salivation | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sweating | Nervous system disorders | Systematic Assessment |
|
| Decreased Interest in Sex | Nervous system disorders | Systematic Assessment |
|
| Impaired Sexual Performance | Nervous system disorders | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Systematic Assessment |
|
| Excitement / Agitation | Nervous system disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Nocturnal/Enuresis | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Menstrual Disturbance | Reproductive system and breast disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Change in Stool Color | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Motor Activity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain / Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Disorientation | Nervous system disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Forgetfulness | Nervous system disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Occurrence of Blank Stare | General disorders | Systematic Assessment |
|
| Myoclonus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011083 |
| Polycyclic Compounds |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| Pain rating, Baseline to week 8 |
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| Interference, Baseline to week 4 |
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| Interference, Baseline to week 8 |
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| Baseline to week 8 |
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| Baseline to week 8 |
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| Baseline to week 8 |
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