Efficacy of Pregnenolone in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Efficacy of Pregnenolone in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615511
• Other study ID #: PRE0504007841
• Secondary ID: 05T-658
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2008
• Last updated: December 18, 2015
• Start date: June 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• placebo pregnenolone
Sugar pill, taken twice a day
• pregnenolone
500mg in tablet form taken orally twice a day

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York
United States	University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare	Piscataway	New Jersey
United States	Weill Medical College of Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SANS - Scale for the Assessment of Negative Symptoms		every month for 4 months	No
Secondary	Quality of Life		every two months for four months	No