Pregnenolone in the Management of Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174889
• Other study ID #: PREG 6/2004
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: May 20, 2008
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: May 2008
• Source: Sha’ar Menashe Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Pregnenolone

Locations

Country	Name	City	State
Israel	Sha'ar Menashe Mental Health	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Sha’ar Menashe Mental Health Center	Beersheva Mental Health Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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. Epub 2005 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
Primary	The Positive and Negative Syndrome Scale.
Primary	The Scale for the Assessment of Negative Symptoms.
Primary	The Calgary Depression Scale for Schizophrenia.
Primary	The Hamilton Scale for Anxiety.
Primary	Extrapyramidal Symptom Rating Scale.
Primary	Barnes Akathisia Scale.
Primary	Abnormal Involuntary Movement Scale.
Secondary	The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).