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This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Pregnenolone | Active Comparator | Pregnenolone |
|
| Arm 2: Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Pregnenolone | Drug | Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. |
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) | The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance. | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
| University of California Performance-based Skills Assessment (UPSA) | The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
| Brief Assessment of Cognition in Schizophrenia (BACS) | The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| The Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes. | Prospective, outcome measures collected over 10 week trial period. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
Subjects with unstable medical illness or neurological illness (seizures, CVA);
Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);
Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;
Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin [HCG] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);
Women who are breast-feeding;
Electroconvulsive therapy (ECT) treatment within the last 3 months;
Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely;
Current active suicidal and/or homicidal ideation, intent, or plan;
Known allergy to study medication.
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| Name | Affiliation | Role |
|---|---|---|
| Christine 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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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Pregnenolone | Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. |
| FG001 | Arm 2: Placebo | Placebo control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Pregnenolone | Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. |
| BG001 | Arm 2: 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 | MATRICS Consensus Cognitive Battery (MCCB) | The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance. | Posted | Mean | Standard Error | T score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
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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 | Arm 1: Pregnenolone | Pregnenolone Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hopitalization | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine E. Marx, MD | VHA Durham | 9192860411 | 3626 | christine.marx@va.gov |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo | Dietary Supplement | Placebo |
|
| Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
| Scale for the Assessment of Negative Symptoms(SANS) | The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance. | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
| Positive and Negative Syndrome Scale (PANSS) |
The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes. |
| Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
| Clinical Global Impressions (CGI) Scale | The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes. | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
Placebo control group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm 2: Placebo | Placebo control group |
|
|
| Primary | University of California Performance-based Skills Assessment (UPSA) | The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. | Posted | Mean | Standard Error | total score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
|
|
| Primary | Brief Assessment of Cognition in Schizophrenia (BACS) | The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance. | Posted | Mean | Standard Error | Z score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
|
|
| Primary | Scale for the Assessment of Negative Symptoms(SANS) | The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance. | Posted | Mean | Standard Error | total score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
|
|
| Secondary | The Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes. | Posted | Mean | Standard Error | total score | Prospective, outcome measures collected over 10 week trial period. |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) | The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes. | Posted | Mean | Standard Error | total score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
|
|
| Secondary | Clinical Global Impressions (CGI) Scale | The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes. | Missing data for a total of 5 participants for the CGI. | Posted | Mean | Standard Error | score | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) |
|
|
|
| 3 |
| 42 |
| 31 |
| 42 |
| EG001 | Arm 2: Placebo | Placebo Placebo: Placebo | 4 | 46 | 38 | 46 |
| Hospitalization for Elevated Glucose | Endocrine disorders |
|
| Medical Admission for Observation | Gastrointestinal disorders |
|
| Breast Cancer Diagnosis | Reproductive system and breast disorders |
|
| Hypersomnia | Nervous system disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Insomnia | Nervous system disorders |
|
| Decreased Appetite | Nervous system disorders |
|
| Increased appetite | Nervous system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Dry mouth | Nervous system disorders |
|
| Cramps | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Tremor | Nervous system disorders |
|
| Increased Salivation | Nervous system disorders |
|
| Palpitations | Cardiac disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Dermatological | Skin and subcutaneous tissue disorders |
|
| Joint pain/ stiffness | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Sweating | Nervous system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Muscle Pain/Stiffness | Musculoskeletal and connective tissue disorders |
|
| Other: "Lucid Dreams" | Nervous system disorders |
|
| Restlessness | General disorders |
|
| Nocturnal/Enuresis | Renal and urinary disorders |
|
| Decreased Interest in Sex | Nervous system disorders |
|
| Vertigo | Nervous system disorders |
|
| Blurred Vision | Eye disorders |
|
| Menstrual Disturbance | Reproductive system and breast disorders |
|
| Nasal Congestion | General disorders |
|
| Peripheral Edema | General disorders |
|
| Malaise | General disorders |
|
| Akathisia | Musculoskeletal and connective tissue disorders |
|
| Excitement/Agitation | Nervous system disorders |
|
| Confusion | Nervous system disorders |
|
| Paresthesia | Nervous system disorders |
|
| Tachycardia | Cardiac disorders |
|
| Increased Motor Activity | Musculoskeletal and connective tissue disorders |
|
| Cold Extremities | Blood and lymphatic system disorders |
|
| Other: "Urinary Retention" | Renal and urinary disorders |
|
| Other: "Head/Neck Twitching" | Musculoskeletal and connective tissue disorders |
|
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