Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174889
Status:
COMPLETED
Last Update Posted:
2008-05-21
First Post:
2005-09-09
Brief Title:
Pregnenolone in the Management of Schizophrenia Patients
Sponsor:
Shaar Menashe Mental Health Center
Organization:
Shaar Menashe Mental Health Center
Study Overview
Official Title:
Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients a Randomised Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pregnenolone is a neurosteroid and possesses intrinsic behavioral and brain effects in animals affecting the GABAA 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 negativedepressive and cognitive symptoms
Detailed Description:
Either pregnenolone 30 mgd or 200 mgd DHEA 400 mgdor 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 DHEAS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None