Trial record 1 of 1 for:    NCT00174889
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Pregnenolone in the Management of Schizophrenia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174889
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 21, 2008
Beersheva Mental Health Center
Information provided by:
Sha’ar Menashe Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pregnenolone Phase 1

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  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients: a Randomised Double-Blind Placebo-Controlled Trial
Study Start Date : January 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
  2. The Positive and Negative Syndrome Scale.
  3. The Scale for the Assessment of Negative Symptoms.
  4. The Calgary Depression Scale for Schizophrenia.
  5. The Hamilton Scale for Anxiety.
  6. Extrapyramidal Symptom Rating Scale.
  7. Barnes Akathisia Scale.
  8. Abnormal Involuntary Movement Scale.

Secondary Outcome Measures :
  1. The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174889

Sha'ar Menashe Mental Health
Hadera, Israel, 38814
Sponsors and Collaborators
Sha’ar Menashe Mental Health Center
Beersheva Mental Health Center
Principal Investigator: Michael S. Ritsner, MD, PhD Sha’ar Menashe Mental Health Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael S Ritsner, Shaar-Menashe MHC Identifier: NCT00174889     History of Changes
Other Study ID Numbers: PREG 6/2004
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Sha’ar Menashe Mental Health Center:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders