Status:
COMPLETED
Prevention of Mood Disorders by Folic Acid Supplementation
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Depression
Bipolar Disorder
Eligibility:
All Genders
14-24 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether daily folic acid supplements can prevent new episodes of mood disorder in young people (aged 14-24 years) of biological parents with current or past h...
Detailed Description
Bipolar disorder and recurrent major depression are life-long disabling illnesses that often first become clinically apparent in the late teenage years or early twenties. People who develop clinical m...
Eligibility Criteria
Inclusion
- aged 14-24 years
- at least one biological parent with history of recurrent major depression or bipolar disorder
- normal blood count and serum vitamin B12 level
- provide written informed consent
- in the case of participants \<16 years have a parent or guardian who will also provide written informed consent
Exclusion
- have significant active medical illness which in the opinion of the Principal Investigator could introduce additional risk factors and/or interfere with study procedures
- have current epilepsy and/or treatment with anticonvulsant drugs
- are, or intended to become,pregnant
- have current or previous Axis 1 disorder on DSM-IV (excluding adjustment disorder)
- are currently taking folate supplements and unwilling to continue
- have known hypersensitivity to folic acid or hydroxybenzoate esters
- taking methotrexate or other drugs that affect folate function
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00459264
Start Date
December 1 2005
End Date
December 1 2011
Last Update
November 23 2016
Active Locations (1)
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1
University Department of Psychiatry
Oxford, Oxfordshire, United Kingdom, OX3 7JX