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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
ProfessorJohnGeddes, University of Oxford
ClinicalTrials.gov Identifier:
NCT00459264
First received: April 10, 2007
Last updated: November 21, 2016
Last verified: November 2016
  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 ]

Enrollment: 112
Study Start Date: December 2005
Study Completion Date: December 2011
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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
University Department of Psychiatry
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
Stanley Medical Research Institute
Investigators
Principal Investigator: John R Geddes, MD FRCPsych University of Oxford
  More Information

Responsible Party: ProfessorJohnGeddes, Professor of Psychiatry, University of Oxford
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: November 21, 2016
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:
Disease
Depression
Bipolar Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016