Pregnenolone in the Management of Schizophrenia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Pregnenolone Neurosteroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pregnenolone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Shaar-Menashe MHC

Principal Investigators

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Michael S. Ritsner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sha'ar Menashe Mental Health Center

Locations

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Sha'ar Menashe Mental Health

Hadera, , Israel

Site Status

Countries

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Israel

References

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Ritsner M, Gibel A, Ram E, Maayan R, Weizman A. Alterations in DHEA metabolism in schizophrenia: two-month case-control study. Eur Neuropsychopharmacol. 2006 Feb;16(2):137-46. doi: 10.1016/j.euroneuro.2005.07.007. Epub 2005 Sep 1.

Reference Type BACKGROUND

PMID: 16139994 (View on PubMed)

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 Oct;30(10):1913-22. doi: 10.1038/sj.npp.1300747.