Status:
UNKNOWN
Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone
Lead Sponsor:
Aga Khan University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 in...
Detailed Description
Vitamin B12 plays an important role in DNA synthesis and neurological function. Its deficiency is associated with hematological, neurological and psychiatric manifestations of which the latter include...
Eligibility Criteria
Inclusion
- 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
- Patients with concurrent unstable medical illness
- History of manic episodes or psychotic illness
- Psychotic symptoms within depressive episode
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00939718
Start Date
April 1 2009
End Date
September 1 2010
Last Update
May 31 2010
Active Locations (1)
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1
Aga Khan University
Karachi, Sindh, Pakistan, 74800