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

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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Pakistan | |
Aga Khan University | |
Karachi, Sindh, Pakistan, 74800 |
Study Chair: | Anwer Siddiqui, PhD | Aga Khan University |
Responsible Party: | Ehsan Ullah Syed ; Associate Professor, Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00939718 |
Other Study ID Numbers: |
081011PSY |
First Posted: | July 15, 2009 Key Record Dates |
Last Update Posted: | May 31, 2010 |
Last Verified: | May 2010 |
depression;vitamin B12;randomized control trial |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders Vitamin B 12 Hydroxocobalamin |
Vitamins Micronutrients Physiological Effects of Drugs Vitamin B Complex Hematinics |