Pregnenolone in the Management of Schizophrenia Patients

May 20, 2008 updated by: Sha'ar Menashe Mental Health Center

Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients: a Randomised Double-Blind Placebo-Controlled Trial

Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. An extensive battery of research instruments will be used for assessment of the following domains of interest: psychopathology, insight, side effects, and cognitive functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of antipsychotic treatment with pregnenolone will be analyzed.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38814
        • Sha'ar Menashe Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Ability and willingness to sign informed consent for participation in the study

Exclusion Criteria:

  • Evidence of organic brain damage, mental retardation, alcohol or drug abuse
  • Prostate nodules or cancer.
  • Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.
  • History of ischemic cardiac disease.
  • Renal disease.
  • Hepatic dysfunction.
  • Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
  • Women with a history of uterine cancer.
  • Patients with a known hypersensitivity to androgens.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
The Positive and Negative Syndrome Scale.
The Scale for the Assessment of Negative Symptoms.
The Calgary Depression Scale for Schizophrenia.
The Hamilton Scale for Anxiety.
Extrapyramidal Symptom Rating Scale.
Barnes Akathisia Scale.
Abnormal Involuntary Movement Scale.

Secondary Outcome Measures

Outcome Measure
The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sha'ar Menashe Mental Health Center

Collaborators

Beersheva Mental Health Center

Investigators

  • Principal Investigator: Michael S. Ritsner, MD, PhD, Sha'ar Menashe Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2008

Last Update Submitted That Met QC Criteria

May 20, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREG 6/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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