Trial · NCT00728728
Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
NCT00728728, Phase 2, Completed, VA Office of Research and Development; results first posted 2017-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia. Trials, record NCT00728728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00728728
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
- NCT number
- NCT00728728
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 88 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Dietary Supplement: Pregnenolone, Placebo
- First posted
- 2008-08-06
- Last updated
- 2017-02-10
- Results first posted
- 2017-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MATRICS Consensus Cognitive Battery (MCCB) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
| Primary | University of California Performance-based Skills Assessment (UPSA) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
| Primary | Brief Assessment of Cognition in Schizophrenia (BACS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
| Primary | Scale for the Assessment of Negative Symptoms(SANS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
| Secondary | The Calgary Depression Scale for Schizophrenia (CDSS) | Prospective, outcome measures collected over 10 week trial period. | 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. |
| Secondary | Positive and Negative Syndrome Scale (PANSS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
| Secondary | Clinical Global Impressions (CGI) Scale | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MATRICS Consensus Cognitive Battery (MCCB) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | T score | MEAN | |
| PRIMARY | University of California Performance-based Skills Assessment (UPSA) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | total score | MEAN | |
| PRIMARY | Brief Assessment of Cognition in Schizophrenia (BACS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | Z score | MEAN | |
| PRIMARY | Scale for the Assessment of Negative Symptoms(SANS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | total score | MEAN | |
| SECONDARY | The Calgary Depression Scale for Schizophrenia (CDSS) | Prospective, outcome measures collected over 10 week trial period. | total score | MEAN | |
| SECONDARY | Positive and Negative Syndrome Scale (PANSS) | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | total score | MEAN | |
| SECONDARY | Clinical Global Impressions (CGI) Scale | Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10) | Missing data for a total of 5 participants for the CGI. | score | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 1: Pregnenolone | Baseline | 30.92 | Standard Error 1.83 | T score |
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 2: Placebo | Baseline | 30.32 | Standard Error 1.40 | T score |
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 1: Pregnenolone | Week 4 | 33.43 | Standard Error 1.75 | T score |
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 2: Placebo | Week 4 | 32.76 | Standard Error 1.72 | T score |
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 1: Pregnenolone | Week 8 | 36.97 | Standard Error 1.90 | T score |
| MATRICS Consensus Cognitive Battery (MCCB) | Arm 2: Placebo | Week 8 | 34.25 | Standard Error 2.11 | T score |
| University of California Performance-based Skills Assessment (UPSA) | Arm 1: Pregnenolone | Baseline | 77.49 | Standard Error 1.63 | total score |
| University of California Performance-based Skills Assessment (UPSA) | Arm 2: Placebo | Baseline | 76.68 | Standard Error 1.76 | total score |
| University of California Performance-based Skills Assessment (UPSA) | Arm 1: Pregnenolone | Week 4 | 77.29 | Standard Error 2.65 | total score |
| University of California Performance-based Skills Assessment (UPSA) | Arm 2: Placebo | Week 4 | 80.12 | Standard Error 1.63 | total score |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Pregnenolone | 42 | |
| Overall Study | STARTED | Arm 2: Placebo | 46 | |
| Overall Study | COMPLETED | Arm 1: Pregnenolone | 38 | |
| Overall Study | COMPLETED | Arm 2: Placebo | 34 | |
| Overall Study | NOT COMPLETED | Arm 1: Pregnenolone | 4 | |
| Overall Study | NOT COMPLETED | Arm 2: Placebo | 12 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | Nervous system disorders | Arm 1: Pregnenolone | 11 | 42 | |
| other | Drowsiness | Nervous system disorders | Arm 2: Placebo | 10 | 46 | |
| other | Hypersomnia | Nervous system disorders | Arm 1: Pregnenolone | 9 | 42 | |
| other | Hypersomnia | Nervous system disorders | Arm 2: Placebo | 8 | 46 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1: Pregnenolone | 8 | 42 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 2: Placebo | 7 | 46 | |
| other | Insomnia | Nervous system disorders | Arm 1: Pregnenolone | 7 | 42 | |
| other | Insomnia | Nervous system disorders | Arm 2: Placebo | 3 | 46 | |
| other | Decreased Appetite | Nervous system disorders | Arm 1: Pregnenolone | 8 | 42 | |
| other | Decreased Appetite | Nervous system disorders | Arm 2: Placebo | 6 | 46 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Pregnenolone | ||
| Total, all-cause mortality | Arm 2: Placebo | ||
| Total, other adverse events | Arm 1: Pregnenolone | 31 | 42 |
| Total, other adverse events | Arm 2: Placebo | 38 | 46 |
| Total, serious adverse events | Arm 1: Pregnenolone | 3 | 42 |
| Total, serious adverse events | Arm 2: Placebo | 4 | 46 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: Pregnenolone vs Arm 2: Placebo: serious adverse events |
Source Trial comparisons
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Tower Planning | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00728728
GET https://conductscience.org/api/trials/v1/NCT00728728/results?page=2