Prevention of Mood Disorders by Folic Acid Supplementation - Full Text View

Sponsors and Collaborators:	University of Oxford Stanley Medical Research Institute
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00459264

Purpose

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	Intervention
Depression Bipolar Disorder	Drug: Folic Acid Drug: Placebo

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Folic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Mood Disorders by Folic Acid Supplementation

Further study details as provided by University of Oxford:

Primary Outcome Measures:

Occurrence of an episode of Axis 1 mood disorder on DSM-IV as determined by the SCID [ Time Frame: Within 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in score on the Altman Mania Rating Scale [ Time Frame: Within 3 years ] [ Designated as safety issue: Yes ]
Correlation between genotypes for folate enzymes and response to folate [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Folic Acid	Drug: Folic Acid Folic acid oral solution 2.5mg/5ml daily for up to 3 years
2: Placebo Comparator Matching placebo for folic acid	Drug: Placebo Matching placebo for folic acid oral solution (2.5mg/5ml)

Show Detailed Description

Eligibility

Ages Eligible for Study:	14 Years to 24 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459264

Locations

United Kingdom, Oxfordshire
University Department of Psychiatry	Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Contact: Ann L Sharpley, PhD 01865 223611 ann.sharpley@psych.ox.ac.uk
Contact: Rena Hockney, RMN 01865 226409 rena.hockney@psych.ox.ac.uk
Principal Investigator: Philip J Cowen, MD FRCPych

Sponsors and Collaborators

University of Oxford

Stanley Medical Research Institute

Investigators

Principal Investigator:

John R Geddes, MD FRCPsych

Oxford University

More Information

Additional Information:

PRE-EMPT study web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Oxford University ( Prof John Geddes )
Study ID Numbers:	04/Q1604/110, 04T-496, 2004-003341-40, 21584/0206/001-0001
Study First Received:	April 10, 2007
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00459264
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:

Folic Acid
Prevention
Depression
Bipolar Disorder
Teenagers

Study placed in the following topic categories:

Folic Acid
Affective Disorders, Psychotic
Depression
Bipolar disorder
Mental Disorders

Bipolar Disorder
Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Vitamin B Complex
Pathologic Processes
Disease
Hematinics
Therapeutic Uses
Growth Substances

Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009