Status:
UNKNOWN
Pregnenolone and L-theanine Augmentation in the Treatment for Schizophrenia and Schizoaffective Disorders
Lead Sponsor:
Sha'ar Menashe Mental Health Center
Collaborating Sponsors:
Tirat Carmel Mental Health Center
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating symptoms. It was suggested that compounds with neuroprotective effects might be useful in the management of ...
Detailed Description
This is a two-year randomized placebo-controlled double-blind investigation of the augmentation of PREG with L-theanine in the management of patients with SZ/SA. The study will consist of two phases: ...
Eligibility Criteria
Inclusion
- Age 18-50 years, men or women.
- DSM-IV criteria for schizophrenia or schizoaffective disorder (American Psychiatric Association 2000).
- Subjects entering the study must score at least 4 on the Clinical Global Impression Scale (CGI-S).
- At least two weeks of ongoing treatment with current antipsychotic agents.
- No change in anticholinergic, or benzodiazepine medications for the pre-treatment stabilization period.
- Stable symptoms throughout the 2 week pre-treatment stabilization period.
- Ability and willingness to sign an informed consent form for participation in the study.
Exclusion
- Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- Unstable medical illness or neurologic illness (seizures, CVA); breast, uterine, or ovarian cancer.
- Patients with impaired renal function or with a history of significant impaired renal function will be excluded.
- Patients with significant suicidal risk will be excluded.
- Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen. \[Female patients will also have a pregnancy test.\].
- Known allergy to study medication.
- Patients receiving mood-stabilizing medications.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01831986
Start Date
January 1 2011
End Date
December 1 2013
Last Update
December 5 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.