- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00560937
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
August 11, 2015 updated by: Durham VA Medical Center
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.
Study Overview
Detailed Description
See brief summary
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VAMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years of age, any ethnic group, either sex
- Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder
- Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
- Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).
- No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.
- No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.
- No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study.
Exclusion Criteria:
- Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.
- Use of oral contraceptives or other hormonal supplementation such as estrogen.
- Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
- Active expression of suicidal or homicidal ideation.
- Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- Female patients who are pregnant or breast-feeding.
- Known allergy to study medication.
- Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the Federal Drug Administration (FDA); patients taking these agents will not be eligible for this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
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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
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Active Comparator: 1
Pregnenolone
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Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
Time Frame: SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
|
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).
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SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
Time Frame: Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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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.
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Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Time Frame: Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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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.
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Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)
|
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.
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Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)
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Clinical Global Impression Scale (CGI-I)
Time Frame: CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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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.
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CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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Mean Score on the Positive and Negative Symptom Scale (PANSS)
Time Frame: Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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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.
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Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine E Marx, MD, MA, Durham VAMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
April 1, 2006
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
November 19, 2007
First Submitted That Met QC Criteria
November 19, 2007
First Posted (Estimate)
November 20, 2007
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VA IRB# 00924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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