Efficacy of Pregnenolone in Patients With Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jason Kim, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00615511
First received: February 1, 2008
Last updated: December 19, 2012
Last verified: December 2012
  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: placebo pregnenolone
Dietary Supplement: pregnenolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pregnenolone in Patients With Schizophrenia

Resource links provided by NLM:


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: June 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Jason J Kim, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Jason Kim, Assistant Professor of Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00615511     History of Changes
Other Study ID Numbers: PRE0504007841, 05T-658
Study First Received: February 1, 2008
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
schizophrenia
schizoaffective disorder
negative symptoms
cognition

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014