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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00459264
First received: April 10, 2007
Last updated: February 2, 2011
Last verified: June 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Mood Disorders by Folic Acid Supplementation

Resource links provided by NLM:

U.S. FDA Resources

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 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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
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

No publications provided

Responsible Party: Prof John Geddes, Oxford University
ClinicalTrials.gov Identifier: NCT00459264     History of Changes
Other Study ID Numbers: 04/Q1604/110, 04T-496, 2004-003341-40, 21584/0206/001-0001
Study First Received: April 10, 2007
Last Updated: February 2, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Folic Acid
Prevention
Depression
Bipolar Disorder
Teenagers

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Folic Acid
Vitamin B Complex
 Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013