Prevention of Mood Disorders by Folic Acid Supplementation
PRE-EMPT
4 other identifiers
interventional
112
1 country
1
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 history of depression or bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Dec 2005
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 10, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 23, 2016
November 1, 2016
5.5 years
April 10, 2007
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of an episode of Axis 1 mood disorder on DSM-IV as determined by the SCID
Within 3 years
Secondary Outcomes (2)
Change in score on the Altman Mania Rating Scale
Within 3 years
Correlation between genotypes for folate enzymes and response to folate
Baseline to end of study
Study Arms (2)
1
ACTIVE COMPARATORFolic Acid
2
PLACEBO COMPARATORMatching placebo for folic acid
Interventions
Folic acid oral solution 2.5mg/5ml daily for up to 3 years
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
University Department of Psychiatry
Oxford, Oxfordshire, OX3 7JX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John R Geddes, MD FRCPsych
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
April 10, 2007
First Posted
April 11, 2007
Study Start
December 1, 2005
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
November 23, 2016
Record last verified: 2016-11