Status:
COMPLETED
L-Theanine in the Management of Schizophrenia
Lead Sponsor:
Sha'ar Menashe Mental Health Center
Collaborating Sponsors:
Stanley Medical Research Institute
Beersheva Mental Health Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The aim of the proposed study is to investigate the efficacy and safety of add-on gamma-glutamylethylamide (L-theanine) versus a placebo for antipsychotic treatment for 8 weeks in a randomized, double...
Detailed Description
This is a two-year randomized placebo-controlled double-blind investigation of the use of augmentative L-theanine in the management of 60 patients with schizophrenia and schizoaffective disorders. We ...
Eligibility Criteria
Inclusion
- Age 18-60 years, men or women
- DSM-IV criteria for schizophrenia or schizoaffective disorder
- At least 4 on the Clinical Global Impression Scale
- At least two weeks of ongoing treatment with current antipsychotic agents.
- 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.
- Renal disease
- Hepatic dysfunction
- Pregnant women
- Patients receiving mood stabilizing medications.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00372151
Start Date
October 1 2006
End Date
December 1 2008
Last Update
December 16 2008
Active Locations (2)
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1
Be'er Sheva Mental Health Center
Beersheba, Israel
2
Sha'ar Menashe Mental Health Center
Hadera, Israel, 38814