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This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pregnenolone |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone | Drug | Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048 | The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms). | SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
| Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS) | The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. | Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
| Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) | The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance. | Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27. | Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Marx, MD, MA | Durham VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VAMC | Durham | North Carolina | 27705 | United States |
Following the screening visit, patients were withdrawn during the placebo lead-in phase and were not randomized for the following reasons: 1. hyponatremia, 2. hospitalization, 3.pneumonia, 4.no show for follow-up study visit, 5.chest pain, 6. elevated prolactin at baseline, 7.prolonged QTc at baseline
Patient recruitment occurred between 8-05 and 4-06 for this single-site study at the Durham VAMC, Durham, NC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnenolone |
|
| FG001 | Placebo | Placebo dosing and tablets were identical to Pregnenolone. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnenolone |
|
| BG001 | Placebo |
| 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 | Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048 | The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms). | Pilot proof of concept study | Posted | Mean | Standard Deviation | units on a scale | SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
|
Adverse events were recorded during each study visit (study visits occurred every two weeks, a total of 5 study visits) for the duration of the 10 week study (following a 2 week placebo lead-in).
Hillside Adverse Event Questionnaire used to obtain Adverse Events.
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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 |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disorientation (date, address, mayor, MD name) | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine E. Marx, MD, MA | Durham Veterans Affairs Medical Center | 919 286-0411 | 7426 | marx0001@mc.duke.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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 (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks |
|
| Clinical Global Impression Scale (CGI-I) | The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms. | CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
| Mean Score on the Positive and Negative Symptom Scale (PANSS) | The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20. | Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
Placebo dosing and tablets were identical to Pregnenolone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo dosing and tablets were identical to Pregnenolone. |
|
|
|
| Secondary | Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27. | Posted | Mean | Standard Deviation | units on a scale | Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward) |
|
|
|
|
| Primary | Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS) | The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. | Posted | Mean | Standard Deviation | units on a scale | Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
|
|
|
|
| Primary | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) | The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance. | Posted | Mean | Standard Deviation | units on a scale | Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
|
|
|
|
| Secondary | Clinical Global Impression Scale (CGI-I) | The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms. | Posted | Mean | Standard Deviation | units on a scale | CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
|
|
|
|
| Secondary | Mean Score on the Positive and Negative Symptom Scale (PANSS) | The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20. | Posted | Mean | Standard Deviation | units on a scale | Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward) |
|
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | Placebo | Placebo dosing and tablets were identical to Pregnenolone. | 0 | 9 | 5 | 9 |
| Decreased interest in sex | General disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Impaired sexual performance | General disorders | Systematic Assessment |
|
| Excitation/agitation | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Muscle pain/stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cold extremities | Cardiac disorders | Systematic Assessment |
|
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| 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 |