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Efficacy of Pregnenolone in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo pregnenolone
pregnenolone
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, negative symptoms, cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
  • Weill Medical College of Cornell University
  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

Pregnenolone

Arm Description

Approximately one third of subjects

Outcomes

Primary Outcome Measures

SANS - Scale for the Assessment of Negative Symptoms

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
February 1, 2008
Last Updated
December 18, 2015
Sponsor
Weill Medical College of Cornell University
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00615511
Brief Title
Efficacy of Pregnenolone in Patients With Schizophrenia
Official Title
Efficacy of Pregnenolone in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, schizoaffective disorder, negative symptoms, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Approximately one third of subjects
Arm Title
Pregnenolone
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo pregnenolone
Intervention Description
Sugar pill, taken twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
pregnenolone
Intervention Description
500mg in tablet form taken orally twice a day
Primary Outcome Measure Information:
Title
SANS - Scale for the Assessment of Negative Symptoms
Time Frame
every month for 4 months
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
every two months for four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason J Kim, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Medical College of Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

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Efficacy of Pregnenolone in Patients With Schizophrenia

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