Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone

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ClinicalTrials.gov Identifier: NCT00939718

Recruitment Status : Unknown

Verified May 2010 by Aga Khan University.
Recruitment status was: Active, not recruiting

First Posted : July 15, 2009

Last Update Posted : May 31, 2010

Sponsor:

Information provided by:

Aga Khan University

Study Description

Brief Summary:

While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting an open label randomized controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will be allocated to each arm of intervention at out patient clinics of the department of Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Dietary Supplement: Vitamin B12	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	268 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Comparison of Vitamin B12 Supplementation and SSRI to SSRI Monotherapy in Treating Depression With Low Normal B12: A Randomized Open Label trialComparison of Vitamin B12 Supplementation to SSRI Versus SSRI Antidepressant Treatment Alone
Study Start Date :	April 2009
Estimated Primary Completion Date :	June 2010
Estimated Study Completion Date :	September 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

MedlinePlus related topics: Antidepressants B Vitamins

Drug Information available for: Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Vitamin B12 with antidepressants Subjects in this arm will receive vitamin B12 supplement (injectable)along with their routine antidepressant treatment as prescribed by their primary physicians. subjects will be blind to their arm allocation and will receive injections in a concealed manner with injection vials covered with foil.	Dietary Supplement: Vitamin B12 Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment. Other Name: Injection Bevidox intramuscular
Placebo Comparator: Placebo injections dextrose water Subjects in this arm will receive placebo injections which will contain only dextrose water. They will also receive 6 injections on a weekly basis and the injection vials will be covered with foil to ensure masking.	Dietary Supplement: Vitamin B12 Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment. Other Name: Injection Bevidox intramuscular

Outcome Measures

Primary Outcome Measures :

Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression. [ Time Frame: 03 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults between ages 18 to 64 years who meet the criteria for a depressive episode as measured by a score of ≥ 16 on first 17 items of HAM-D (Urdu version.
Patients with low normal B12 levels in serum (>191 but < 300 pg/ml)
Those who will provide informed consent

Exclusion Criteria:

Patients with concurrent unstable medical illness
History of manic episodes or psychotic illness
Psychotic symptoms within depressive episode

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939718

Locations

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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

Investigators

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Study Chair:	Anwer Siddiqui, PhD	Aga Khan University

More Information

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Responsible Party:	Ehsan Ullah Syed ; Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier:	NCT00939718 History of Changes
Other Study ID Numbers:	081011PSY
First Posted:	July 15, 2009 Key Record Dates
Last Update Posted:	May 31, 2010
Last Verified:	May 2010

Keywords provided by Aga Khan University:


depression;vitamin B12;randomized control trial

Additional relevant MeSH terms:

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Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders Vitamins Hydroxocobalamin Vitamin B 12 Vitamin B Complex	Antidepressive Agents Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Psychotropic Drugs Hematinics

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