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Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
This study is ongoing, but not recruiting participants.
Sponsored by: Durham VA Medical Center
Information provided by: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00560937
  Purpose

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
Schizophrenia
Dietary Supplement: Pregnenolone or Placebo

MedlinePlus related topics: Schizophrenia
Drug Information available for: Pregnenolone
U.S. FDA Resources
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

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • BACS, MATRICS, SANS [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CDSS, PANSS, CGI [ Time Frame: Prospective ] [ Designated as safety issue: No ]

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
1: Active Comparator
Pregnenolone
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
2: Placebo Comparator
Placebo
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

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-65 years of age, any ethnic group, either sex
  2. DSM IV diagnosis of schizophrenia or schizoaffective disorder
  3. Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
  4. Patient cohort enriched for moderate to severe cognitive symptoms (composite BACS score 0-3 SD below the mean).
  5. No change in antipsychotic regimen for > 4 weeks.
  6. No change in anticholinergic, benzodiazepine, or mood stabilizer medications for > 4 weeks.
  7. 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:

  1. Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
  2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
  3. Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
  4. Active expression of suicidal or homicidal ideation.
  5. Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
  6. Female patients who are pregnant or breast-feeding.
  7. Known allergy to study medication.
  8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the FDA; patients taking these agents will not be eligible for this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560937

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
  More Information

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

Keywords provided by Durham VA Medical Center:
Schizophrenia
Pregnenolone
Cognition
Negative Symptoms

Study placed in the following topic categories:
Schizophrenia
Signs and Symptoms
Mental Disorders
Neurologic Manifestations
Psychotic Disorders
Neurobehavioral Manifestations
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009