Efficacy of Pregnenolone in Patients With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Dietary supplement: placebo pregnenolone; Dietary supplement: pregnenolone

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
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell University
    • White Plains, New York, United States, 10605
      • Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SANS - Scale for the Assessment of Negative Symptoms	every month for 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life	every two months for four months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Stanley Medical Research Institute
• Investigators: Principal Investigator: Jason J Kim, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: cognition; schizophrenia; schizoaffective disorder; negative symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: PRE0504007841; 05T-658 (Other Grant/Funding Number: Stanley Medical Research Institute)