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

NCT00939718 | Unknown

• 1 other identifier: 081011PSY
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression;vitamin B12;randomized control trial

Outcome Measures

Primary Outcomes (1)

• Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression.

  03 months

Study Arms (2)

Vitamin B12 with antidepressants

ACTIVE COMPARATOR

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

Placebo injections dextrose water

PLACEBO COMPARATOR

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

Interventions

Vitamin B12 DIETARY_SUPPLEMENT

Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.

Also known as: Injection Bevidox intramuscular

Placebo injections dextrose water; Vitamin B12 with antidepressants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Anwer Siddiqui, PhD

  Aga Khan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 31, 2010

Record last verified: 2010-05

Locations

PA (1)