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
  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:


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 April 23, 2014