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Sponsored by: |
Durham VA Medical Center |
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Information provided by: | Durham VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00560937 |
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.
Condition | Intervention |
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Schizophrenia |
Dietary Supplement: Pregnenolone or Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia |
Enrollment: | 28 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | March 2008 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pregnenolone
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Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
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2: Placebo Comparator
Placebo
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Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
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See brief summary
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 ) |
Study ID Numbers: | VA IRB# 00924 |
Study First Received: | November 19, 2007 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00560937 |
Health Authority: | United States: Food and Drug Administration; United States: Institional Review Board; United States: Federal Government |
Schizophrenia Pregnenolone Cognition Negative Symptoms |
Schizophrenia Signs and Symptoms Mental Disorders Neurologic Manifestations |
Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features |
Nervous System Diseases |