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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

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

  Show Detailed Description

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

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U.S. FDA Resources

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



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


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Ages Eligible for Study:   18 Years to 65 Years   (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

Information from the National Library of Medicine

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
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Study Chair: Anwer Siddiqui, PhD Aga Khan University

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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vitamins
Vitamin B 12
Hydroxocobalamin
Antidepressive Agents
Vitamin B Complex
Serotonin Uptake Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Psychotropic Drugs
Hematinics
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents