Efficacy of Pregnenolone in Patients With Schizophrenia - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University Stanley Medical Research Institute
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00615511

Purpose

Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Dietary Supplement: pregnenolone	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Pregnenolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Pregnenolone in Patients With Schizophrenia

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

SANS - Scale for the Assessment of Negative Symptoms [ Time Frame: every month for 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: every two months for four months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Dietary Supplement: pregnenolone Titration over first four weeks up to 500mg per day, in the form of five small pills to be taken by mouth each morning and evening, with or without food.
2: Experimental High dose dietary supplement intervention	Dietary Supplement: pregnenolone Titration over first four weeks up to 500mg per day, in the form of five small pills to be taken by mouth each morning and evening, with or without food.

Detailed Description:

Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.

Eligibility

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

Criteria

Inclusion Criteria:

Age 18-65
Diagnosis of schizophrenia or schizoaffective disorder
No new medication for past 3 months and stable dose for past 4 weeks
SANS (Negative symptom) score of 20 or above

Exclusion Criteria:

Significant dementia or head trauma.
Seizure during past year.
Substance dependence in past 6 months or positive urine drug screen.
History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
Steroid metabolism disorder, e.g.Cushings or Addison's disease.
Taking steroids other than birth control or post-menopausal hormones.
Women who are pregnant or nursing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615511

Contacts

Contact: Adam J Savitz, MD, PhD	914 997 4394	ads9002@med.cornell.edu
Contact: Judith M English, MA	914 682 6974	jme2003@med.cornell.edu

Locations

United States, New York
Weill Medical College of Cornell University	Recruiting
White Plains, New York, United States, 10605
Contact: Adam J Savitz, MD, PhD 914-997-4394 ads9002@med.cornell.edu
Contact: Judith M English, MA 914 682 6974 jme2003@med.cornell.edu
Principal Investigator: Adam J Savitz, MD, PhD
Sub-Investigator: Judith M English, MA
Sub-Investigator: Leeann Grant, BA
Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10065
Contact: Jason Kim, MD 212-821-0712 jak9001@med.cornell.edu
Contact: Judith M English, MA 914 682 6974 jme2003@med.cornell.edu
Principal Investigator: Jason Kim, MD
Sub-Investigator: Judith M English, MA

Sponsors and Collaborators

Weill Medical College of Cornell University

Stanley Medical Research Institute

Investigators

Principal Investigator:

Adam J Savitz, MD, PhD

Weill Medical College of Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( Adam J Savitz, MD, PhD )
Study ID Numbers:	PRE0504007841, 528-444
Study First Received:	February 1, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00615511
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

schizophrenia
schizoaffective disorder
negative symptoms
cognition

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 14, 2009