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Prevention of Mood Disorders by Folic Acid Supplementation (PRE-EMPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00459264
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : November 23, 2016
Stanley Medical Research Institute
Information provided by (Responsible Party):
ProfessorJohnGeddes, University of Oxford

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.

Condition or disease Intervention/treatment Phase
Depression Bipolar Disorder Drug: Folic Acid Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Mood Disorders by Folic Acid Supplementation
Study Start Date : December 2005
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Folic Acid
Drug: Folic Acid
Folic acid oral solution 2.5mg/5ml daily for up to 3 years
Other Name: Lexpec PL 0427/0034

Placebo Comparator: 2
Matching placebo for folic acid
Drug: Placebo
Matching placebo for folic acid oral solution (2.5mg/5ml)

Primary Outcome Measures :
  1. Occurrence of an episode of Axis 1 mood disorder on DSM-IV as determined by the SCID [ Time Frame: Within 3 years ]

Secondary Outcome Measures :
  1. Change in score on the Altman Mania Rating Scale [ Time Frame: Within 3 years ]
  2. Correlation between genotypes for folate enzymes and response to folate [ Time Frame: Baseline to end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459264

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United Kingdom
University Department of Psychiatry
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
Stanley Medical Research Institute
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Principal Investigator: John R Geddes, MD FRCPsych University of Oxford
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Responsible Party: ProfessorJohnGeddes, Professor of Psychiatry, University of Oxford
ClinicalTrials.gov Identifier: NCT00459264    
Other Study ID Numbers: 04/Q1604/110
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Keywords provided by ProfessorJohnGeddes, University of Oxford:
Folic Acid
Bipolar Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Folic Acid
Vitamin B Complex
Physiological Effects of Drugs