Pregnenolone in the Management of Schizophrenia Patients - Tabular View

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Pregnenolone in the Management of Schizophrenia Patients

This study has been completed.

Study NCT00174889. Last updated on May 20, 2008. Information provided by Sha’ar Menashe Mental Health Center

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Pregnenolone in the Management of Schizophrenia Patients

Official Title ^†

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

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.

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary 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 Measure ^†

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

Condition ^†

Schizophrenia

Intervention ^†

Drug: Pregnenolone

MEDLINE PMIDs

16139994, 15870835

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

January 2005

Completion Date

May 2007

Eligibility 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.

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Administrative Information Fields

NCT ID ^†

NCT00174889

Organization ID

PREG 6/2004

Secondary IDs ^††

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

Information Provided By

Sha’ar Menashe Mental Health Center

Verification Date

May 2008

First Received Date ^†

September 9, 2005

Last Updated Date

May 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.