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Pregnenolone in the Management of Schizophrenia Patients
This study has been completed.
First Received: September 9, 2005   Last Updated: May 20, 2008   History of Changes
Sponsor: Sha’ar Menashe Mental Health Center
Collaborator: Beersheva Mental Health Center
Information provided by: Sha’ar Menashe Mental Health Center
ClinicalTrials.gov Identifier: NCT00174889
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Pregnenolone
 Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients: a Randomised Double-Blind Placebo-Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Schizophrenia
Drug Information available for: Pregnenolone
U.S. FDA Resources

Further study details as provided by Sha’ar Menashe Mental Health Center:

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

Estimated Enrollment: 60
Study Start Date: January 2005
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174889

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

Publications:
Ritsner M, Gibel A, Ram E, Maayan R, Weizman A. Alterations in DHEA metabolism in schizophrenia: Two-month case-control study. Eur Neuropsychopharmacol. 2005 Aug 31; [Epub ahead of print]
Ritsner M, Gibel A, Maayan R, Ratner Y, Ram E, Biadsy H, Modai I, Weizman A. Cortisol/Dehydroepiandrosterone Ratio and Responses to Antipsychotic Treatment in Schizophrenia. Neuropsychopharmacology. 2005 May 4; [Epub ahead of print]

Responsible Party: Shaar-Menashe MHC ( Michael S Ritsner )
Study ID Numbers: PREG 6/2004
Study First Received: September 9, 2005
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00174889     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sha’ar Menashe Mental Health Center:
Schizophrenia
Pregnenolone
Neurosteroids

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009



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