NCT00514410

Brief Summary

To determine whether giving folic acid to people with depression will help their antidepressants work better. If folate does help antidepressants to work better, then it will provide a safe, simple and cheap way of improving the treatment of depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jul 2007

Typical duration for phase_4 depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

February 1, 2009

Enrollment Period

3.8 years

First QC Date

August 9, 2007

Last Update Submit

October 11, 2011

Conditions

Depression

Keywords

DepressionFolateFolic acidAntidepressants

Outcome Measures

Primary Outcomes (1)

  • Self rated symptoms of depression using the Beck Depression Inventory

    Repeated measures up to 6 months after initiation of folic acid/placebo

Secondary Outcomes (9)

  • Clinician rated depression using the Montgomery-Asberg Depression Rating Scale

    Repeated measures up to 6 months after initiation of folic acid/placebo

  • Clinician rated symptom severity using the Clinical Global Impression scale

    Repeated measures up to 6 months after initiation of folic acid/placebo

  • Health status using the SF12

    Repeated measures up to 6 months after initiation of folic acid/placebo

  • Adverse events

    Repeated measures up to 6 months after initiation of folic acid/placebo

  • Cost Utility using the EuroQol, resource use questionnaire and medication history

    Repeated measures up to 6 months after initiation of folic acid/placebo

  • +4 more secondary outcomes

Study Arms (2)

Folic Acid

EXPERIMENTAL
Drug: Folic Acid

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Folic AcidDRUG

Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment

Folic Acid
PlaceboDRUG

Matching placebo taken once a day for three months

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only patients aged 18 or over
  • ICD-10 diagnosis of moderate to severe depression
  • Able to give informed consent (not delirious, actively psychotic or with severe communication or learning disability)
  • Able to complete the research assessments

You may not qualify if:

  • are folate deficient
  • are B12 deficient
  • have knowingly taken supplements containing folic acid within 2 months
  • suffer from psychosis
  • are already participating in another research project
  • are pregnant or planning to become pregnant
  • are taking anticonvulsants
  • have a serious, advanced or terminal illness with a life expectancy of less than 1 year
  • have recently started treatment for a medical condition which has not yet been stabilised
  • are taking lithium
  • have had a diagnosis or treatment for any malignant disease or any related condition such as intestinal polyposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

North West Wales Trust

Bangor, Gwynedd, LL57 2PW, United Kingdom

Location

Swansea University

Swansea, Swansea, SA2 8PP, United Kingdom

Location

Cardiff University

Wrexham, Wrexham, LL13 7YP, United Kingdom

Location

Related Publications (1)

  • Roberts SH, Bedson E, Hughes D, Lloyd K, Menkes DB, Moat S, Pirmohamed M, Slegg G, Thome J, Tranter R, Whitaker R, Wilkinson C, Russell I. Folate augmentation of treatment - evaluation for depression (FolATED): protocol of a randomised controlled trial. BMC Psychiatry. 2007 Nov 15;7:65. doi: 10.1186/1471-244X-7-65.

    PMID: 18005429BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ian T Russell, PhD, HonFRCGP, FRCP Edin, FFPH

    Swansea University

    PRINCIPAL INVESTIGATOR

  • Keith Lloyd, MBBS, MSc, MRC Psych, MSc, MD

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 12, 2011

Record last verified: 2009-02

Locations

GB(3)