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Completed

NCT Number: NCT00615511

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare, Piscataway, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

placebo pregnenolone

Dietary Supplement

Sugar pill, taken twice a day

pregnenolone

Dietary Supplement

500mg in tablet form taken orally twice a day

Primary outcomes

  1. SANS - Scale for the Assessment of Negative Symptoms

    Time frame: every month for 4 months

Secondary outcomes

  1. Quality of Life

    Time frame: every two months for four months

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2008
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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