Back to resultsPregnenolone in the Management of Schizophrenia Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Pregnenolone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Pregnenolone, Neurosteroids
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.
Sites / Locations
- Sha'ar Menashe Mental Health
Outcomes
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).
Full Information
NCT ID
NCT00174889
First Posted
September 9, 2005
Last Updated
May 20, 2008
Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Beersheva Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00174889
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Beersheva Mental Health Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Pregnenolone, Neurosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pregnenolone
Primary Outcome Measure Information:
Title
The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
Title
The Positive and Negative Syndrome Scale.
Title
The Scale for the Assessment of Negative Symptoms.
Title
The Calgary Depression Scale for Schizophrenia.
Title
The Hamilton Scale for Anxiety.
Title
Extrapyramidal Symptom Rating Scale.
Title
Barnes Akathisia Scale.
Title
Abnormal Involuntary Movement Scale.
Secondary Outcome Measure Information:
Title
The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S. Ritsner, MD, PhD
Organizational Affiliation
Sha'ar Menashe Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sha'ar Menashe Mental Health
City
Hadera
ZIP/Postal Code
38814
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16139994
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. doi: 10.1016/j.euroneuro.2005.07.007. Epub 2005 Sep 1.
Results Reference
background
PubMed Identifier
15870835
Citation
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.
Results Reference
background
PubMed Identifier
20584515
Citation
Ritsner MS, Gibel A, Shleifer T, Boguslavsky I, Zayed A, Maayan R, Weizman A, Lerner V. Pregnenolone and dehydroepiandrosterone as an adjunctive treatment in schizophrenia and schizoaffective disorder: an 8-week, double-blind, randomized, controlled, 2-center, parallel-group trial. J Clin Psychiatry. 2010 Oct;71(10):1351-62. doi: 10.4088/JCP.09m05031yel. Epub 2010 Jun 15.
Results Reference
derived
Learn more about this trial
Pregnenolone in the Management of Schizophrenia Patients
We'll reach out to this number within 24 hrs