Efficacy of Pregnenolone in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615511
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : December 21, 2015
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jason Kim, Weill Medical College of Cornell University

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Dietary Supplement: placebo pregnenolone Dietary Supplement: pregnenolone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pregnenolone in Patients With Schizophrenia
Study Start Date : June 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
Approximately one third of subjects
Dietary Supplement: placebo pregnenolone
Sugar pill, taken twice a day
Experimental: Pregnenolone Dietary Supplement: pregnenolone
500mg in tablet form taken orally twice a day

Primary Outcome Measures :
  1. SANS - Scale for the Assessment of Negative Symptoms [ Time Frame: every month for 4 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: every two months for four months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615511

United States, New Jersey
University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
Piscataway, New Jersey, United States, 08854
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Stanley Medical Research Institute
Principal Investigator: Jason J Kim, MD Weill Medical College of Cornell University

Responsible Party: Jason Kim, Assistant Professor of Psychiatry, Weill Medical College of Cornell University Identifier: NCT00615511     History of Changes
Other Study ID Numbers: PRE0504007841
05T-658 ( Other Grant/Funding Number: Stanley Medical Research Institute )
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Jason Kim, Weill Medical College of Cornell University:
schizoaffective disorder
negative symptoms

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders