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Sponsored by: |
Durham VA Medical Center |
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Information provided by: | Durham VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00639886 |
This study will investigate adjunctive pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Dietary Supplement: Pregnenolone or Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia |
Estimated Enrollment: | 88 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pregnenolone: Active Comparator
Pregnenolone
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Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
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Placebo: Placebo Comparator
Placebo
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Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
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See brief summary
Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
Contact: Jennifer C Naylor, PhD | 919 286-0411 ext 7722 | naylorjc@duke.edu |
United States, North Carolina | |
Durham VAMC | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Christine E Marx, MD MA | Durham VAMC |
Responsible Party: | Durham Veterans Affairs Medical Center ( Christine E. Marx, MD MA ) |
Study ID Numbers: | Pending (not yet submitted) |
Study First Received: | March 14, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00639886 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
Schizophrenia Pregnenolone Cognition Negative Symptoms |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |