Efficacy of Pregnenolone in Patients With Schizophrenia

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00615511

Collaborator

Stanley Medical Research Institute (Other)

100

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2007

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

SANS - Scale for the Assessment of Negative Symptoms [every month for 4 months]

Secondary Outcome Measures

Quality of Life [every two months for four months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare	Piscataway	New Jersey	United States	08854
2	Weill Medical College of Cornell University	New York	New York	United States	10065
3	Weill Medical College of Cornell University	White Plains	New York	United States	10605